1
RegulationsontheApproval,Notification,andEvaluationofQuasi-Drugs
MinistryofFoodandDrugSafety(MFDS)NoticeNo.2010–65(Establishedon09/15/2010)
MFDSNoticeNo.2011–5(Revidon02/01/2011)
MFDSNoticeNo.2012–129(Revidon12/27/2012)
MFDSNoticeNo.2013–2(Revidon01/16/2013)
MFDSNoticeNo.2013–9(Revidon03/08/2013)
MFDSNoticeNo.2013–33(Revidon04/05/2013)
MFDSNoticeNo.2014–76(Revidon02/12/2014)
MFDSNoticeNo.2014–153(Revidon09/04/2014)
MFDSNoticeNo.2014–169(Revidon10/15/2014)
MFDSNoticeNo.2014–177(Revidon10/29/2014)
MFDSNoticeNo.2015–69(Revidon09/25/2015)
Article1(Purpo)
Chapter1GeneralProvisions
ThepurpoofthisNoticeistoprovidedetailedproceduresandrequirementsformanufacturingorimporting
approval(notification)ofquasi-drugs,andproductssubjecttothesafetyandefficacyevaluationandscientificreview
ofspecificationsandtestingmethodsforquasi-drugs,datarequirements(scope,descriptionandwaiver),andrelevant
criteriaandmanagementofdatapursuanttoArticles31,42,and76ofthePharmaceuticalAffairsActandArticles4,
5,8to13,39,40,and57to59oftheRulesontheSafetyofDrugs,etc.
Article2(Definitions)
ThetermsudinthisNoticeshallbedefinedasfollows:
1.“Activeingredient”meansasubstanceoragroupofsubstances(includingherbalmedicines,ofwhich
pharmacologicallyactiveingredient,tbeenidentifiedyet)expectedtomanifest,directlyorindirectly,
theindicationsofquasi-drugs.
2.“Newmaterial”meansasubstanceoragroupofsubstancesthathavenotbeenuddomesticallyasanactive
ingredientofdrugsorquasi-drugs;however,forquasi-drugsfallingundersubparagraph7(a)ofArticle2ofthe
PharmaceuticalAffairsAct,italsomeansasubstanceoragroupofsubstancesthathavenotbeenud
domesticallyasanexcipientofquasi-drugs.
3.“Herbalmedicinalproduct”,asenfromthewesternmedicinepointofview,meansapreparationmadewithraw
materialsorsubstancesderivedfromnaturalmaterialsthatisnotudfortreatmentpurposintheoriental
r,apreparation,thoughoriginatedfromanaturalmaterial,madebyextractingandrefininga
particularingredient,shallnotbeconsideredasherbalmedicinalproduct.
4.“Combinationproducts”meansquasi-drugscontainingtwoormoreactiveingredientsincludingextracts(suchas
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herbalmedicinalproducts)fromtwoormoreplantsandextractsfromtwoormoreorgansofthesameanimal
(e.g.:anextractfromliverandstomachofapig),ticmaterialsthataredifficulttoparateorrefine
individualingredient,orunnecessarytoprocesssuchoperations(e.g.:o-,m-,orp-Cresol),oranextractfromthe
sameplant(provided,thatevenifextractedfromthesameplant,iftheactiveingredientxtractedfromdifferent
partsarenoticeablydifferent,asScopoliaeRhozomaextract,itshallbeexcluded.)andanextractfromthesame
organofthesameanimal(e.g.:gastricmucousmembraneextractofapig)shallbeconsideredasasingle-
componentproduct.
5.“Sample”meansmaterialscollectedinareasonablemanner,suchasrandomsampling.
6.“Actualvalue”meansavalueobtainedfromactualmeasurementtobeudforactualstatisticalanalysiswith
outlierxcluded.
7.“Actualstatisticalvalue”meansavalueobtainedfromstatisticalanalysisofactualvalues
8.“Disinfectantsandincticidesforpreventinginfectiousdia”meansoneofthefollowingproducts:
(a)Productsudforthepurpoofexpellingorcontrollingharmfulpathogencarryingincts(includinglarva
andimagoofmosquitoes,ants,flies,fleas,lice,andcockroaches)causingdiasandsanitaryhazardsforpeople.
(b)Productsudforthepurpoofsterilizationanddisinfection,notdirectlyappliedtopeople,animalsor
medicaldevices.
(c)“Rodenticides”meansproductsudforthepurpoofcontrollingpathogencarryingrodentscausingdias
inpeople.
9.“Booster”meansasubstanceoragroupofsubstancesthatenhancestheactionofactiveingredients,thoughit
doesnothaveinherentlysterilizing,incticidalandrodenticidaleffects.
10.“Inhalableproducts”meansproducts,suchascigarette-typeproductsspecifiedinsubparagraph2(e)ofthe
DesignationoftheScopeofQuasi-Drugs(MFDSNotice),thatareudthroughrepeatedanddirectinhalationor
productsspecifiedinsubparagraph2(j)oftheDesignationoftheScopeofQuasi-Drugsthatmaybeudthrough
prolongedorrepeatedandindirectinhalation.
Chapter2ApplicationforApprovalorNotificationofQuasi-drugsandDataRequirements
Article3(ApprovalorNotificationProcess)
(1)Quasi-drugsthataresubjecttonotificationpursuanttoArticles31(4)and42(1)ofthePharmaceuticalAffairs
Actshallbeasfollows;howeverproductssubjecttosafetyandefficacyevaluationpursuanttoArticles21and44
shallbeexcluded:
tslistedintheKoreanPharmacopoeia(NoticeofMFDS),compendiaordrugformulariesrecognizedby
theMinisterofMinistryofFoodandDrugSafety(hereinafterreferredtoastheMinisterofMFDS);however,
productsthathavenotbeenapproveddomesticallyshallbeexcluded.
tsforwhichspecificationsandtestmethodsarenotifiedbytheMinisterofMFDS.
tsthatcomplywiththemanufacturingstandardsnotifiedbytheMinisterofMFDS.
(2)Manufacturersorimporterswhofiledforapproval(notification)ofquasi-drugsshallbeapprovedordeclareas
specifiedbelow:
ductswiththesamespecificationsandquantitiesofactiveingredient(s),dosageform,androuteof
administration(orapplication),theyshallberegardedas,andapproved(notified)asoneproduct;however,itis
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notapplied,iftheuniquenatureofaproductisrecognizedwithinascopeofthesamespecificationsorifa
,approval(notification)formanufactureandimportshallberegardedas
paratecasand,thus,shallbeappliedwithdifferentproductnames.
hstandingsubparagraph1,forproductstobemixeduppriortou(e.g.:adoublebatchofadeveloperand
dyeforhaircoloringproducts)orwhenamix-badmanufacturingisjustifiable,theymaybeapproved(or
notified)thetaste(flavor),color,orshapediffer,theymaybeapproved(ornotified)asone
productwithonecertificateofapproval(notification).
hstandingsubparagraphs1and2,quasi-drugsfallingundersubparagraphs1and2(a),(b),(f),and(i)of
theDesignationoftheScopeofQuasi-Drugs(MFDSNotice)maybeapproved(notified)asapackagewith
differentproductnames,r,insuchaca,ifthetype,
quantitiesanddosageformoftheactiveingredientarethesame,eventhoughtherestoftheingredientsare
different,theymaybeapproved(ornotified)withonecertificateofapproval(notification).
(3)Forquasi-drugsintendedforexportonly,theapplicationforproductapproval(notification)maybesubmitted
onlywithspecifications,edbytheimporteroftheproduct,insteadofinformationonsafetyandefficacy,
specifications,andtestmethodspursuanttoArticle4(1)1and2oftheRulesontheSafetyofDrugs,a
ca,theMinisterofMFDSmaygrantapproval(oracceptnotification)onthebasisofthodocumenttc.
(4)Quasi-drugsfallingundersubparagraph7(c)ofArticle2ofthePharmaceuticalAffairsActshallcomplywith
Chapter5Approval,NotificationandReviewofDisinfectantsandIncticides,etcforpreventingInfectiousDias
Article4(ProcessingofChangestoApprovalorNotificationofQuasi-Drugs)
(1)Ifapprovedornotifiedquasi-drugsspecifiedinArticle3areintendedtobechangedinaccordancewithArticle8
(1)oftheRulesontheSafetyofDrugs,etc.,suchchangesshallcomplywithprovisionsofArticles7to18ofthe
Rules.
(2)Notwithstandingparagraph(1),forthefollowingminorchanges,dossiers(includingelectronicdocuments)
describingsuchchangesmaybeprovidedforapprovalornotificationpursuanttoArticle8(4)oftheRulesonthe
SafetyofDrugs,etc:
stotheproductname(applicableonlyforsingle-componentproducts,forwhichtheactiveingredientor
prescriptioninformationisudastheproductname),drugsubstancesandtheirquantities,ortermsudin
specificationsandtestmethods,rdancewithchangestotermsofsubstancesorpreparationslistedin
theKoreanPharmacopoeia,KoreanPharmaceuticalCodex,SpecificationsandTestMethodsforQuasi-Drugsand
othersasnotifiedbytheMinisterofMFDS,andforeigncompendiaaslistedintheDesignationofCompendia
andMonographs(MFDSNotice);
ectionofmanufacturingmethod,changestothecontainersorpackaging(exceptforimmediatecontainer
orpackaging)thatdonotaffectthestability;
ectionofmanufacturingmethod,changestothemanufacturer’saddressduetochangeofadministrative
district.
ectionofindications(efficacyandeffects),dosageandadministrationandprecautions,uofeasyterms
designatedandnotifiedbytheMinisterofMFDS.
ectionofdrugsubstancesandtheirquantities,changestothetypeoftarcolorant
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tothespecificationsofadditiveswithinthescopeofthestandardsandcompendianotifiedbytheMinister
ofMFDSpursuanttosubparagraph1.
(3)Forchangespursuanttoeachsubparagraphofparagraph(2),themanufacturerorimporterofthequasi-drugshall
specifythedateandchangesin“ChangesandRegulatoryActions,etc.”onthebacksideoftheapproval(or
notification)certificate..
(4)Forchangesaslistedintheaboveparagraph(2),thequasi-drugmanufacturerorimportershallsubmittothe
MinisterofMFDSortheCommissionerofthecompetentRegionalOfficeofMFDStheapplicationofchangesin
accordancewithArticle5(1),togetherwiththeelectronicmediacontainingtheinformationbytheenddateofthe
monthwheretheapprovalornotificationdatebelongs,onchangesoccurredforthepast1yearfromtheenddateof
themonthpriortothemonthwheretheinitialapprovalornotificationdatebelongs.
Article5(PreparationofApplicationforProductApprovalorNotification)
(1)Theapplicationformanufactureandimport,ornotificationofquasi-drugsshallbepreparedinanappropriate
manneronthebasisofattacheddocumentsspecifiedinthisNotice,andcontaininformationasspecifiedinArticles7
bmittingattacheddocuments,theyshallbeelectronicallypreparedusingasoftwareprogram
designatedbytheMinisterofMFDSandtheelectronicmediacontainingthofiles(suchasCD,disk)shallbe
provided.
(2)Supportingdata(includingdomesticandoverasapprovalinformation,datarequirementspursuanttothe
ManufacturingStandardsforDrugs,etc.(MFDSNotice))ontheprescription,indications,dosageandadministration,
ductssubjecttonotificationpursuanttoArticle3(1),supportingdataonthe
activeingredientandtheirquantities,dosageform,andspecificationsandtestmethodsverifyingthattheycorrespond
tooneofthesubparagraphsinArticle3(1)shallbeattached;however,forsolidandliquidpreparationsamongquasi-
drugsthatcomplywiththeManufacturingStandardsforDrugs,etc.,documentsonthestandardsandtestmethodsare
notrequired.
(3)Notwithstandingparagraph(1),ifoneintendstoapplyforapprovalof(ordeclare)manufacturingorimporting
ofproducts,forwhichdatasubmissionhavebeenmodified(harmonized)pursuanttoArticle50,applicationshallbe
preparedaccordingtosuchmodification;however,itisnotappliedwhenoneintendstorequestreviewandattach
safetyandefficacydataorsubmitthe“resultsofsafetyandefficacyevaluation.”
(4)Forimportedproducts,thefollowingdocumentsonthemanufactureandsaleoftheproductshallbesubmitted;
however,ifitisdifficulttosubmitsuchdocumentsatthetimeoftheapplication,theapplicantsmayindicatethe
expectedduedateforsubmissionwithintheperiodforprocessingoftheapplicationandsubmitthembytheduedate.
Thecertificatesonthemanufactureandsaleshallbeissuedwithintwoyearspriortotheapplicationdate(Certificates
issuedbeforemaybeacceptable,dependingontheissuancesystemofthemanufacturingorregisteringcountry,or
publicagencythatareresponsibledirectlyorindirectlyforapprovalormanagementoftheproduct).
-drugsfallingundersubparagraph1,2(a)and2(b)oftheoftheDesignationoftheScopeofQuasi-Drugs
(MFDSNotice)
(a)Acertificateofmarketingauthorizationdescribingtheproductname,drugsubstancesandtheirquantities,
indications,tratingthattheproductismarketedinoroutsideofthemanufacturingcountry,signedby
theresponsiblepersonofthemanufacturerandofficiallynotarizedbyacompetentauthority(apublicagencyin
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thecountryresponsibledirectlyorindirectlyforapprovalormanagementoftheproduct)
-drugsnotcoveredbysubparagraph1
(a)Acertificateofmanufacturedescribingtheproductname,drugsubstancesandtheirquantities(active
ingredientanditsspecifications,r,
omissionmaybeallowedifsuchinformationiscontainedinthecertificateofmarketingasspecifiedinthebelow
clau(b)),thenameandaddressofthemanufacturerwhichdemonstratestheproductislegitimatelymanufactured
inthecountryofproduction.
(b)Acertificateofmarketingauthorizationdescribingtheproductname,drugsubstancesandtheirquantities
(activeingredientanditsspecifications,r,omissionmaybe
allowedifsuchinformationiscontainedinthecertificateofmanufactureasspecifiedintheaboveclau(a)),the
nameandaddressofthemanufacturerissuedbythegovernmentorapublicagencythatgrantedapprovalor
registeredtheproduct(acompetentauthorityresponsibledirectlyorindirectlyforapprovalandmanagementofthe
productinthecountryofsale)
(5)Whenapplyingfortheinitialapprovalofsanitarymasks,theresultsofleakageratetestingshallalsobeprovided
kageratesshallbenogreaterthan25.0%fortheKF80rating,nogreaterthan11.0%for
theKF94rating,andnogreaterthan5.0%fortheKF99rating.
Article6(DataRequirementsforApprovalandNotification)
(1)Thefollowinginformationshallbedescribedintheapprovalornotificationcertificatesofmanufactureandsale
orimportofquasi-drugsinaccordancewithArticle12,13,or59oftheRulesontheSafetyofDrugs,etc:
tName
mberandclass
bstancesandtheirquantities
ance
cturingmethods(addressofmanufacturingsitesforactiveingredientsandallmanufacturingprocess
shallbespecified;however,themanufacturerofactiveingredientsmaynotbespecifiedforsubparagraph2(a)
and(b)oftheDesignationoftheScopeofQuasi-Drugs(MFDSNotice))
tions(efficacyandeffects)
andadministration
tionsinu
gunits
eandexpirydate(shelf-life)
icationsandtestmethods
cturer(includingthecontractmanufacturerwhenapplicable)andimporter(includingtheoriginal
manufacturer)
alconditions
(2)Forchangestotheappearanceonly(externalshapeorcolor,etc.)accordingtoparagraph(1),specificationsand
testmethodsmaynotberevid.
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Article7(ProductName)
(1)Theproductnameidenticaltotheonealreadyapprovedornotifiedforothermedicinalproductsorquasi-drugs
r,ifdifferentimportersimportthesameproductfromthesamemanufacturer,thenamesof
importersshallbeindicatedrespectivelyforeasydiscrimination..
(2)Inprinciple,theproductnameshallbeindicatedasfollows:
randnameisintendedtobeindicated,thenameofquasi-drugmanufacturerorimporterinaccordance
withArticles31(4)and42(1)(includingauniqueabbreviationsorsymbolicreprentationhereinafterreferred
toasthe“nameofbusiness”),r,nameofbusiness
r,thenameoftheactiveingredientofasingle-componentproduct,thenamesaslistedin
therelevantnoticeforproductsnotifiedbytheMinisterofMFDS,andprescriptioninformationforproducts
madeusingprescriptiontion,for
quasi-drugsfallingundersubparagraphs1and2(a),(b),(f),and(i),dosageformmaybeomitted.
randnameisnotindicated,“thenameofbusiness,thenameoftheactiveingredient(forasingle-
componentproduct)ortheprescriptionname,anddosageformshallbeindicated.”
ingsforsanitarymasks(e.g.:KF80,KF90,K99)shallbeindicatedintheparenthesis.
(3)Ifoneintendstouaproductnamethatareamendedbysimplyaddingorreplacingaletter,wordornumber,etc.
(e.g.:△△-A,△△—F,compositeOOO,etc.)oftheproductnamealreadyapprovedornotified,suchnamemaybe
udonlyfortheproducthavingsimilarindicationsastheoneapprovedornotified..
(4)Fordosageform,thetermspecifiedintheGeneralRulesforPreparationsintheKoreanPharmacopoeiashallbe
r,ifitisrecognizedthatitisanewdosageformsuchasjellyorthatitisarequiredtoparately
managedsuchastheentericgranules,sustained-releatablet,effervescenttablets,sugar-coatedtablets,film-coated
tablets,softcapsule,hardcapsule,andemulsion,etc.,suchnamemaybeindicated..
(5)Ifitisnecessarytoindicatethequantitiesoftheactiveingredient(mass,volume,potency)ofasingle-component
product,itshallbestatedwiththedosageformandtheunit(e.g.;OOsodiumfluoridesolution0.2mg).Andfor
combinationproducts,theadministrationtime(morningorevening),taste(flavor),intendedu(bleachingordye
remover),eindicated,andifnecessary,indicatedbyprescription.
(6)Thenameudforexportshallbeindicatedintheproductstandards(4.1ProductStandardsunderDrugGMPin
Appendix1oftheRulesontheSafetyofDrugs,dardquivalenttothis)toberegardedas“namefor
export”approvedornotifiedinaccordancewiththisNotice.
(7)Ifoneintendstoamendtheproductname,suchamendmentshallbeappropriateinaccordancewithArticle11(2)
oftheRulesontheSafetyofDrugs,etc.
Article8(CodeNumberandClass)
(1)CodenumbershallcomplywiththeRegulationsonCodesforClassificationofQuasi-Drugs(MFDSInternal
Rules).
(2)Classshallbeindicatedasquasi-drugs.
Article9(Composition)
(1)Dosageformshallbelectedtomaximizetheefficacyoftheactiveingredientandensurethestabilityandsafety.
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Thecomposition(drugsubstancesandtheirquantities)shallbeconsistent
withindications,dosageandadministration,eringthenatureoftheproduct,intendedu,names,
specificationsofsubstances,andtheirquantities(mass,volume,potency,oramountud)shallbespecifiedfor
individualingredientaccordingtotheguidancedefinedinparagraph(2).However,whenextractsorderivativesare
ud,thenames(specifications)tion,thecontentsoftheactive
ingredientshallbereasonableandjustifiableonthebasisofthepharmacologicaldata,clinicaltrialresults,
combinationproducts,intendedushallbevalidforindividualingredient.
(2)Theintendeduofsubstancessuchasactiveingredientanddiluentsshallbespecifiedbyproductorpreparation,
andtheactiveingredientandadditives(accordingtotheamountofadministrationororderofadministrationudin
themanufacturingprocess)shallbeindicatedasfollows:
idedpower,dividedgranulesordividedpills,content“inonepouch(massornumberofpills)or“perone
rving(massornumberofpills).”
lets,capsules,pills(dividedpillsareexcluded),ortrochescontent“inaunitpreparation[tablets,capsules,
pills,etc.](mass).”
ders,liquids,ointments,creams,lotions,gels,pastesandemulsions,t“in100mL”or“in100
g”(v/v,w/v,/w/w);however,forpowder-typesyrupscontent“in100g”(includingtheamountofsolvent),and
fordisposablepreparations“inaunitcontainer[1bottle,ample,etc.](do).”
ductsdirectlyattachedtotheskin,content“in1sheet(theareaandmass)”or“inaunitarea(e.g.:1cm2)”;
however,forcontentindicatedinaunitarea,thesizeofeachsheet(2x2cm2,4x2cm2,etc.)
osols,content“in100g”(paratelyindicatingtheamountsoftheoriginalsolutionandthepropellant).
erpreparationsthatdonotcorrespondtotheabove-mentioneditems,butrequiredtobestatedinan
individualunit,content“inaunitdosageform[oneitem,onepiece,etc.](massorvolume).”
(3)Thenamesandspecificationsofindividualsubstanceshallcomplywiththefollowing:
paragraphs2(a)to(e),
tho,forwhichattachedspecificationsareud,commonnamesorotherappropriatenameshowingthenature
ofthesubstancesshallbeindicatedinKorean.
icationsshallbedescribedaccordingtooneofthefollowing:
(a)SubstanceslistedintheKoreanPharmacopoeia:“Pharmacopoeia”or“KP”
(b)Substanceslistedincompendia:title(oracronym)oftherelevantcompendium
(c)SubstanceslistedintheKoreanHerbal(HerbalMedicines)Pharmacopoeia(MFDSNotice):“HerbalMedicine
Specifications”
(d)SubstanceslistedintheKoreanQuasi-DrugCodex(MFDSNotice):“KQC”
(e)SubstanceslistedaxcipientsintheStandardsandSpecificationsforFoodAdditives(MFDSNotice):“Food
Additives”
(f)Rawmaterialslistedaxcipients(productsforinternaluonlyareexcluded)intheJapaneQuasi-DrugRaw
MaterialCodex:“JQRC”
(g)Drugsubstanceslistedaxcipients(productsforinternaluonlyareexcluded)intheJapaneDrugAdditive
Codex:“JDAC”
(h)Specificationsofsubstancesthatdonotcorrespondtotheitems(a)to(g),andarepreparedbythebusinesswho
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filedforapprovalornotification:“EnclodSpecifications”or“”
(i)Notwithstandingsubparagraphs(a)to(h),herbalmedicinesthataredried,cutorrefinedintheiroriginalform,
andofwhichthequalityhasnotbeenverified,maybeindicatedasthe“originalherbalmedicine.”Forsubstances
thatarespecifiedasdrugadditivesinsubparagraphs1,2(a),(b),(c),(f),(g),(i),and3oftheDesignationofthe
ScopeofQuasi-Drugs(MFDSNotice),andwhospecificationsaredefinedinPart4Additivesforquasi-drugsof
theKoreanQuasi-DrugCodex(MFDSNotice),theappropriatespecificationsmaybestatedrespectively.
(j)Amongdrugsubstancesoffiber,rubberorpapersudforsanitarypurpos,thesubstanceswho
specificationsarelistedintheKoreanIndustrialStandards(KS)maybeindicatedas“KS.”
(k)SubstanceslistedintheKoreanPharmaceuticalCodex(MFDSNotice):KPC
(4)Activeingredientanditsquantity(mass,volume,potency,oramountud)shallbesafeandeffectiveonthebasis
ofthetoxicitytestdata,pharmacologicalactiondata,clinicaltrialdata,anddataontheu(otherliteratures,etc.)and
shallcomplywiththefollowing:
iaforfluorinecontentsintoothpastesshallbeasfollows:
(a)Criteriaforindividualsubstance
Sodiummonofluorophosphate:≤1.14%(1,500ppmasfluorine)
Sodiumfluoride:≤0.33%(1,500ppmasfluorine)
Stannousfluoride:≤0.6%(1,500ppmasfluorine)
N,N,N'-tris-(2-hydroxyethyl)-N'-octadecyl-1,3-diaminopropanedihydrofluoride:≤1.97%(1,500ppmas
fluorine)
(b)Whentheabovesubstancesaremixedup,thetotalcontentoffluorineshallbenogreaterthan1,500ppm.
tractedherbalmaterialisudasanactiveingredient,thenameoftherawherbalmaterialanditsquantity
(amountud),thetypeoftheextractedliquid(itmaybeomittedforpurifiedwater)andyieldrate(e.g.:ginng
50%ethanolextract:101)awherbalmaterialispulverized,thequantityoftherawherbal
materialshallbeclearlystated(e.g.:licoricepowder:10065).
(5)Additivesandtheirquantitiesshallcomplywiththefollowing:
ciple,thequantitiesofalladditivesudshallbestated;however,theamountofthemaindiluentmaybe
indicatedinacertainrange,ifjustifiable(e.g.:differenceinamountsadministeredinthesummerorwinter
ason),orifadditivesthatcomplywiththeKoreanPharmacopoeiaorcompendiaareudforcreams,ointments,
itivesudinminorvolumeasfollows,amountmaybeindicatedas“optimumdo.”
(a)Coatingagent,pills,entericcoatingcapsules,slipmodifiers,polishingagent
(b)Sweeteningagent,coloringagent,flavoringagent
(c)Suspendingagents,emulsifier,dissolutionsupplements
(d)Stabilizer,isotonicsolution,pHregulator,viscosityregulator
(e)Solvent,bacompound(includingcapsules)
ipientsotherthandrugsubstance,tholistedintheKoreanPharmacopoeiaorcompendia,specifiedinthe
Appendix7oftheRegulationsontheApproval,Notification,andReviewofQuasi-Drugs(MFDSNotice),or
otherexcipientswhofunctionsparpharmaceuticallyappropriatewhenconsideringreliabledataontheiruin
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Koreaorforeigncountries,thatdonothavedirectpharmacologicaleffects,andthatdonotcompromithe
efficacyorqualitycontroloftheproductshallbeud..However,ifanactiveingredientisudasanexcipient,
dailydooftheexcipientshallnotexceed1/5oftheminimumdailydoforthesamerouteofadministration.
Ifexceeded,pharmaceuticallyappropriatedataonsuchformulationandreferencespublishedinKoreaorforeign
countriesshallbeprovided.
ndcontentsofprervativesshallmeettherequirementsspecifiedinAppendix1“PrervativesforQuasi-
DrugsandtheirRangeofU..
orantsudinquasi-drugsshallcomplywiththerequirementsspecifiedintheDesignation,Specifications
andTestMethodsforTarColorantsforDrugs,etc.(MFDSNotice);however,itisnotappliedwhentarcolorants
areudincertainpartsofarepellant(band-type)thatarenotinadirectcontactwiththehumanbodyas
specifiedinsubparagraphs1(a)1),(b),(c)1)and8),and2(c)intheDesignationoftheScopeofQuasi-Drugs
(MFDSNotice);orinproductsthatarefilledinacontainertoreducetherisksofaccidentalintakebypeopleor
animals,suchaxtirpators,inhibitors,andinct-attractingpesticidesasspecifiedinsubparagraph2(c);andin
productsthatarenotdirectlyappliedtothehumanbodyasspecifiedinsubparagraph3(a)2).
Article10(Appearance)
(1)ThecharacteristicappearanceandshapeoftheproductshallbedescribedinaccordancewiththeKorean
or,shape,materialtype,anddosageform(-shape
cottonsanitarypad)r,thematerialoftheproductmaynotbespecifiedifitisunnecessary
(e.g.:incticides,hairdyeproduct).
ciple,fordosageform,thetermspecifiedintheGeneralProvisionsforPreparationsoftheKorean
r,ifthedosageformisnotlistedintheKoreanPharmacopoeia(e.g.:fiber,
rubberorpapersudforsanitarypurpo,anti-smokingaid,etc.),orifitisneededtobeparatelymanaged
(e.g.:entericgranules,sustained-releatablet,effervescenttablets,sugar-coatedtablets,film-coatedtablets,soft
capsule,hardcapsule,emulsion,etc.),suchnamemaybeindicated.
sulestheappearanceoftheenclodsubstancesshallbespecified(e.g.:transparentsoftcapsule
containingyellowliquid,hardcapsulecontainingwhitepowderswithblueonthetopandyellow,onthebottom
greensoftcapsulecontainingbrownmi-solidmaterial,hardcapsulecontainingbrownpowderwithblueonthe
topandwhiteonthebottom)
tedpills,theappearanceoftheenclodmaterialsshallbeindicated(e.g.:brownpillsplatedwithgold).
er,rubberorpapers,etc.(e.g.:band-aids)thatareudforsanitarypurpos,andwhomaterialtype
affectstheindicationsanddosageandadministration,andforwhichtheshapeofthecontainerneedtobe
indicated(e.g.:yellowsuspendingagentcontainedinacontainertobesprayedinparticularamounts,etc.),the
appearanceshallbedescribedindetail(e.g.:spongepresdwithawhiteporoussyntheticresin,disposable
polyurethanefilmcoveredwithanadhesivematerialononeside).Andifitdeemsnecessary,astructuraldiagram
includingtheshapeandsize(e.g.:externalphoto,floorplan,etc.)shallbedescribed..
(2)Forproductsmanufacturedindifferentappearances,theappearanceshallbeindicatedforeachpurpoasfollows:
“formedicalinsurance,”“forexport,”or“formilitarysupply”,etc.
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Article11(ManufacturingMethod)
(1)Themanufacturingmethodshallbereasonableandjustifiablefromphysicochemical,biological,bioengineering,
andpharmaceuticalperspectivesonthebasisofthecontemporaryscientificknowledgeandtechnologies.
(2)Forpreparations,theflowchartshowingthewholeproductionprocessandstep-by-stepdescriptionshallbe
providedindetailpursuanttoAppendix2oftheGuidelinesforDescriptionofManufacturingMethods,andshallbe
portingdatashallbeprovidedinaccordancewithsubparagraph4.
nicsolventsareudinthemanufacturingprocess:
(a)Itshallbejustifiablefromthepharmaceuticalperspective.
(b)Itshallnotexercidirectpharmacologicaleffectsandbeudinsafedosage.
(c)Itshallnotcompromithesafetyorqualitycontroloftheproduct.
(d)Intendedu,name,specificationsandquantities,olventshallbeindicated.
holeorpartofthemanufacturingprocessortestingiscommissionedtootherdrugmanufacturersand
conductedusingtheirfacilitiesandequipmentspursuanttotheStandardsforFacilitiesofManufacturers,
ImportersandSalesBusinessofPharmacyandDrugs,etc.(PresidentialDecree),thenameandaddressof
contractmanufacturer,eclearlyindicated.
inishedproductcontainsanimals-derivedsubstancesorsuchsubstancesareudinthemanufacturing
process,stanceofruminantoriginisud,
informationonthelectionofthesubstance(thecountryoforigin,ageoftheruminant,etc.),ortheprocessing
methodtopreventtheinfectionoftheTransmissibleSpongiformEncephalopathy(TSE)shallbeadditionally
providedasmentionedinthebelow:
(a)[Asubstanceofanimalorigin]derivedfrom[thepartud]of[thenameoftheanimal]iscontainedorud.
(b)InordertopreventtheinfectionoftheTransmissibleSpongiformEncephalopathy(TSE),[thenameofthe
substanceofanimalorigin]obtainedbycollecting[thepartud]fromhealthy[thenameoftheruminant]of[age
oftheruminant]from[thecountryoforigin]thatisprocesdby[theprocessingmethod]isud.
ssaryduetothenatureoftheproduct,aparatesub-ctionforproductdesignmaybeaddedtodescribe
thereasonforlectionofthedosageform,drugsubstancesandtheirquantities.
(a)Ifanyspecialprocessmethodisadopted,datajustifyinglectionofthedrugsubstancesandtheirquantities
ud,suchasthereasonforlectionofexcipientsandmixingratio,andifnecessary,thebiologicalevaluation
dataandjustificationofproductdesignshallbeprovided.
(3)Paragraphs(1)and(2)shallapplyfordispensingoffinishedquasi-drugsproducts..
(4)Ifnecessary,,ifthecomparabilityofthe
finishedproductsisdemonstrated,ca,themethodshallbe
indicatedas
(5)Ifaspecialcontainerisudforincticidestoreducetherisksofaccidentalpoisoning,thematerialandstructure
ofsuchacontainershallbespecified.
(6)Paragraphs(1)to(5)shallapplyforimportedproducts.
(7)Ifitisnecessarytoirradiatefinishedproductsforsterilization,operatingparameters(irradiationdo,time,and
others)shallbespecifiedandstabilitydata(threelots),includingcomparativedataondegradationproductsdetected
inirradiatedornon-irradiatedproducts,shallbeprovided.
11
Article12(Indications)
Informationonindicationsshallbedescribedasfollows:
ationonindicationsshallbeprovidedinmedicaltermsandonthebasisofobviousandclearsupporting
dataonpharmaceuticalactivityoftheproduct.
hatarevagueandindefinite,areredundantorexaggerated,ormayleadtomisunderstanding,misu,or
abushallnotbeud.
si-drugsthataresubjecttonotificationpursuanttoArticle3(1),indicationsshallcomplywiththo
ductsthatcomplywiththeManufacturingStandardsforDrugs,etc.
indicationsshallmeetthemanufacturingstandards,andinothercas,shallcomplywithregulationsprescribed
bytheMinisterofMFDS.
balmedicines,indicationsshallbedescribedincontemporarytermsonthebasisofmedical/herbal
medicinedictionaries,aguideforherbaldrugcodex,andotherspecificationsprescribedbytheMinisterofMFDS,
ral,intendedushallbestatedas“treatment,improvement,relieforsupplementforspecific
symptomsundercertainconditionorca”.But,ifjustified,r,ifthereisnoobjective
justificationforinterpretationofterms,suchinterpretationmaybeacceptableifitcomplieswithsubparagraphs1
to6badonthereviewofattacheddocuments.
ndicationsarelimitedtospecificpopulations(badongender,age,orothers),suchinformationshallbe
clearlydescribed.
binationproducts,allindicationsofindividualdrugsubstancesshallnotbedescribed,inprinciple.
Unlessotherwijustified,itionor
potentiationeffects,objectivesupportingdatashallbeprovided.
Article13(DosageandAdministration)
Informationondosageandadministrationshallbeprovidedasfollows:
shallbereasonableandjustifiableonthebasisofpharmacologicalandpharmaceuticaldata,andclinical
data,etc.,andconsistentwithcompositionandindications,tion,do,administrationtime(if
necessary,indicatespecificallyas“beforemeal”,“aftermeal”,“betweenmeals”)andfrequency,e
specifiedindetail.
hstandingsubparagraph1,forquasi-drugsinaccordancewithsubparagraph7(a)ofArticle2ofthe
PharmaceuticalAffairsAct,itmaybestatedas“appropriateamountshallbeappliedtotheaffectedarea.”
However,forproductswithspecificinstructionsforu,suchinstructionsmaybestatedadditionallyaccordingto
subparagraph1.
intendedtobeadministeredtospecificpopulations(badongender,age,orothers),inappropriatedosage
icular,forquasi-drugsforinfantsorchildren,
forcertainspecialcas,proportional
reductionofadultdoshallnotbeud.
ductsformultipleadministrations,suchaspediatricproducts,theyshallbepharmaceuticallyappropriate
productsorpreparations.
12
si-drugssubjecttonotificationpursuanttoArticle3(1),theindicationsshallcomplywiththoalready
ductssubjecttotheManufacturingStandardsforDrugs,omplywithsuch
manufacturingstandards,andinothercas,theyshallcomplywithregulationsprescribedbytheMinisterof
MFDS.
mandexpressionthatmaycauabuorhighlight
certaincharacteristicsshallnotbeud.
Article14(PrecautionsinU)
(1)Allinformationonsafety(includingtheadditives)requiredtoassuresafeandreasonableuofthequasi-drugs
formationshallbepreparedincontemporarytermsonthebasisofmedical/herbalmedicine
dictionaries,aguideforherbaldrugcodex,andotherspecificationsprescribedbytheMinisterofMFDS,y
understanding.
(2)Forquasi-drugssubjecttonotificationpursuanttoArticle3(1),informationonprecautionsforushallcomply
withthoalreadyapprovedornotified,andproductssubjecttotheManufacturingStandardsforDrugs,etc.,itshall
rcas,itshallcomplywithspecificationsprescribedby
cautionsshallbedescribedasfollows:
dministerthisproducttothefollowingpatients:Listthepatientstowhomadministrationoftheproductis
prohibitedwhenconsideringthetypeorsymptomsofthedia,complications,personalandfamilymedical
history,predisposition,possibilityofpregnancy,breastfeeding,genderorotherfactors,eventhoughwho
diaorsymptomscorrespondtotheindications(thescopeofefficacyandeffects)ofthequasi-drug;and
patientswhodiaorsymptomsdonotcorrespond,butverysimilartotheindicationsofthequasi-drug,thus,
xpressions,suchas“Donotadministerthisproducttothe
followingparts(indicatethebodypart)”maybestated.
dminister(oru)thisproductinparallelwiththefollowingproducts:Statementthattheproductshall
notbeudwithotherquasi-drugsofthesamekindoreffectsorthatmaycaudruginteractions.
hefollowingactionswhilethisquasi-drugisadministered(orud):actionsthatshallnotbeperformed
whilethequasi-drugisadministered(orud)shallbestatedasfollows:
(a)Warningthatthisproductshallnotbeadministered(orud)tobreastfeedingwomenshallbestatedifthe
product(orsubstances)maybetransferredandcarryarisktothebabythroughbreast-milk.
(b)Ifariousaccidentmayoccurduetoadverreactionscaudbyadministration(oru)ofthequasi-drug
whileengaginginaparticularoccupationoractivity,listtherelevantadverreactionsandincludewarningthat
suchoccupationsoractivitiesshallbeavoidedwhiletheproductisadministered(orud)..
(c)Ifthequasi-drugmayinteractwithaparticularfoodordrinksuchasalcohol,warningthatsuchfoodordrink
shallnotbetakenwhilethequasi-drugisadministered(orud)shallbestated.
(d)Otherwarningsneededtopreventclinicallysignificantadverreactionsoraccidentsshallbestated.
lowingpersonshallconsultaphysician,dentist,orapharmacistbeforetaking(orusing)thisquasi-drug:
Thecaswherethisquasi-drugshallnotbeadministered(orud)toahealthypersonshallbestated,ifthereisa
highriskofadverreactionsconsideringthetypeorsymptomsofdia,complications,personalandfamily
medicalhistory,predispositions,possibilityofpregnancy,breast-feeding,genderorotherfactorsoftheperson.
13
ollowingcas,administration(oru)ofthisquasi-drugshallbestoppedimmediatelyandconsulta
physician,dentist,,bringtheattachedinstructionsforconsultation,ifpossible:adver
reactionsthatmaywornorcontinueiftheadministration(oru)ofthequasi-drugiscontinuedshallbestated
foreachaffectedarea,andtheinitialadverreactionsthatmayberecognizedbyanordinarypersonshallbe
stated,tion,follow-upmeasuresifthereisnoimprovementinthesymptomsafterthequasi-
drugwasudforacertainperiodoftimeormultipleadministrationsshallbestated,inthisca,theperiodor
numberofadministrationsshallbeindicatedindetail.
recautionsinadministration(oru)ofthisquasi-drug:minorordurableadverreactionxpectedto
occurconsideringthepharmacologicalefficacyofthequasi-drug,andotherprecautionsshallbestated.
tionsinstorage:Informationontemperature,humidity,sunlight,estatedindetailwithinthe
s,dependingonthenatureofthe
preparations,generalprecautionsshallbestatedasfollows:
(a)Storebeyondthechildren’sreach.
(b)Chanore,storetheproductin
theoriginalcontainerandalittightly.
Article15(PackingUnit)
(1)Thepackageunitofquasi-drugsshallbeassmallaspossibleforaneasyandconvenienthandling,anditshallbe
consistentwithitsdosageandadministrationmethod.
(2)Forliquidproducts,thepackingunitshallbeindicatedas“200mLorlessfordisposablepackaging”and“400-
500ml”foreconomicpackaging;however,exceptionsmaybeallowedifspecialcharacteristicsarerecognizedwhen
consideringthedosageformordosage,orifitisjustifiablewhenconsideringtheintendedpurpo.
(3)Forotherpackageunitsthatdonotcorrespondtoparagraph(2),thepackingunitshallbeindicatedas“in-hou
packingunit”formanufacturing,or“packingunitofthemanufacturer”forimporting.
Article16(StorageConditionandPeriodofU(Shelf-life))
(1)Inordertoassurethestabilityoftheproductconsideringthephysicochemicalcharacteristics,thetypesof
containersshallbecategorizedasaled,tight,andhermeticcontainer,etc,andspecificstorageconditions(e.g.:store
at2-8℃,refrigerated,etc.)andprecautions(e.g.:keepawayfromlight,etc.),edescribed.
(2)Periodofushallbeindicatedas“Periodofu:Omonthsfromthedateofmanufacture,”andcomplywiththe
soshallapplytorevisions:
thatisapprovedbadonthesafetyandefficacydatapursuantto‘Chapter3EvaluationofSafetyand
Efficacy.’
ntendstomanufactureanitemsameastheonealreadyapprovedornotified,itsperiodofumaybe
applied,andsuchperiodshallnotexceed36months;however,ifthepharmaceuticalsafetyneedstobeidentified,
safetytestdataorothersupportingdatashallbeprovided.
rtoextendtheperiodofuforaproductthathasbeenapprovedornotified,long-termstabilitydatashall
beprovided..
14
Article17(SpecificationsandTestMethods)
(1)SpecificationsandtestmethodsshallbepreparedinaccordancewithChapter4‘ReviewofSpecificationsand
TestMethods’inamannerthatassuresappropriatequalitycontrol.‘SpecificationsandTestMethods’shallbe
indicatedas“Appendix,”If‘StandardsandTestMethodsoftheQuasi-Drugs(MFDSNotice)’isapplied,itshallbe
indicatedas“InaccordancewiththeSection“OOO”intheStandardsandTestMethodsConcerningQuasi-Drugs.”
However,forproductsthatcorrespondtotheprovisotoArticle5(2),itshallbeindicatedas“in-houstandards.”
Article18(Manufacturer,etc.)
(1)Ifthewholeorpartofthemanufacturingprocessortestingiscommissionedtoothermanufacturersofdrugs,etc.,
thenameandaddressofthecontractedmanufacturershallbeprovided.
(2)Forimportedproduct,theaddressofthemanufacturerandmanufacturingsites,tedonthecertificateof
manufactureshallbeprovided.
Article19(ApprovalCondition,etc.)
(1)Forquasi-drugsforexport,Article4(1)6oftheRulesontheSafetyofDrugs,icles7to18ofthis
itaryorgovernmentsupply(forstockpileu),theaboveprovisionsalsomaynotapply
r,ifoneintendstollaproduct
domesticallythathasbeenapproved,forimport,ormilitaryorgovernmentsupply,conditionsforsuchpurposmay
bewaivedbadonthereviewofsafety,efficacy,andspecificationsandtestmethodspursuanttoChapters3and4
andGMPfordrugspursuanttoArticle4(1)6oftheRulesontheSafetyofDrugs,etc.,providedthattheproductis
notrestrictedbyArticle11oftheRulesontheSafetyofDrugs,ca,suchproductsshallcomplywith
Articles7through18.
(2)Ifoneintendstoapplyforapprovalornotificationofmanufacturedorimportedproductsinconnectionwith
transferand/orassumptionunderArticle8oftheRulesontheSafetyofDrugs,etc.,approvalmaybegrantedor
notificationmaybeaccepted,providedthatallconditionspreviouslyimpodonthetransferoraretransferred.
Article20(ApprovalofCigarette-TypeAnti-SmokingAids)
(1)Harmfulsubstancesofacigarette-typeanti-smokingaidshallnotexceedthefollowingcriteriapercigarette,and
nicotineshallnotbedetected:
10mg;
monoxide10mg.
(2)Forcigarette-typeanti-smokingaids,thefollowingshallbedescribedonthefrontorrearsideoftheexternal
packagingforeachrecognition:
g
1)iveumaycaulungcanceror
otherdias,andinparticular,harmfultopregnantwomenandadolescence.
2)Theleveloftarandcarbonmonoxidecontainedinthisproductisalmostequivalenttocigarettes.
softarandcarbonmonoxideinonepieceofcigarette(e.g.:TarOOmg,carbonmonoxideOOmg)
(3)Whenmeasuringharmfulingredientsindicatedintheexternalpackaging,theacceptablemarginoferrorshallbe
15
asfollows:
:if5mgormore,within±20%;iflessthan5mg,within±1mg
monoxide:if5mgormore,within±20%;iflessthan5mg,within±1mg
(4)Amountsofharmfulingredientsincigarette-typeanti-smokingaidsshallbeidentifiedaccordingtothefollowing
standards:
:MeasurementstandardsofInternationalOrganizationforStandardization(ISO)4387;
monoxide:MeasurementstandardsofInternationalOrganizationforStandardization(ISO)8454
ne:MeasurementstandardsofInternationalOrganizationforStandardization(ISO)10315
Chapter3SafetyandEfficacyEvaluation
Article21(Productssubjecttosafetyandefficacyevaluation):Safetyandefficacyevaluationinaccordancewith
Article4(1)1and9oftheRulesontheSafetyofDrugs,econductedforquasi-drugsfilingforapproval
ornotificationofproductsorchangestosuchproducts;however,thisisnotappliedtoanyofthefollowing:
tswiththesametype,specificationsandquantitiesofactiveingredient,(forliquidproducts,concentration),
dosageform,indications,anddosageandadministrationasthothathavebeenapprovedornotified.
tsthatarelistedintheKoreanPharmacopoeiaorcompendiaorproductsforwhichspecificationsandtest
methodsarenotifiedbytheMinisterofMFDS;however,forproductslistedinacompendium,supporting
documentssuchasdrugformulariesdemonstratingtheircurrentuinthecountryshallbeprovided.
onproducts(includingpapers)udforsanitarypurpoandquasi-drugssubjecttotheManufacturing
StandardsforDrugs,etc.,productsusingasactiveingredientssubstanceslistedintheKoreanPharmacopoeiaor
compendia,orothersubstancesnotifiedbytheMinisterofMFDS,orapproved;productslistedinforeigndrug
formularies(Physicians’DeskReference,PDRinU.S.,drugformularyinJapan,ABPIDataSheetCompendium
inU.K.,RoteListeinGermany,VidalinFrance,L'iniformatoreFarmaceuticoinItaly,ArzneimittelKompendium
derSchweizinSwitzerland,andCompendiumofPharmaceuticalsandSpecialtiesinCanada);orproductswith
acertificateofmanufactureissuedbytherelevantcountry,demonstratingthattheyaresoldinthecountryas
generaldrugs.
(2)Notwithstandingparagraph(1),drugsfallingunderanyofthefollowingaresubjecttosafetyandefficacy
evaluationandinthisca,dataspecifiedinArticles23and24shallbeprovided:
r,safetyandefficacy
evaluationmaybewaivedforsubstancesthatfallunderanyofthefollowing:
(a)SubstanceslistedintheKoreanPharmacopoeia,KoreanPharmaceuticalCodex,SpecificationsandTest
MethodsforQuasi-Drugs,KoreanHerbalCodex,orcompendia
(b)Substancesthathavebeenuddomesticallyandamixturemadeofthesubstances(includingflavoring
agents)
(c)RawmaterialsregisteredintheStandardsandSpecificationsofFoodAdditives.
(d)RawmaterialslistedintheJapaneQuasi-Drugs,RawmaterialsCodexandJapaneDrugAdditiveCodex
(e)Deleted.
(f)Substanceswithdrugformulariesasspecifiedinparagraph(1)3orotherreliabledataontheiruinforeign
16
countries
ntendstofileforapprovalofchangesregardingsafetyandefficacy(indications,dosageandadministration
andtypesorquantitiesofboosters,etc)oftheproductthathavebeenapproved;however,simplechangesin
precautionsforu,ncainformation,si-drugsthathavebeenalreadyapproved,
RegulationsontheManagementofSafetyInformationforDrugs,etc.(MFDSNotice)r,itis
appliedwherechangesareintendedforindications,dosageandadministrationetc,withinascopethatis
consistentwiththeManufacturingStandardsforDrugs,etc..
ntendstoamendapprovalconditionsfromexportsaletodomesticsale.
stancethathasnotbeenudasanadditiveofinhalableproducts(drugsorquasi-drugs)domesticallyis
udinaninhalableproduct.
Article22(DataRequirementsforSafetyandEfficacyevaluation)
(1)Datarequiredforsafetyandefficacyevaluationofquasi-drugsshallbepreparedusingAnnexForm1,anddata
specifiedinArticles23through25shallbeprovided.
(2)DatasubmissionshallcomplywiththerequirementsofArticle25,andforindividualproduct,thelistindex
numbersandpagenumbersofdatashallbeindicatedintheorderspecifiedinArticle23;however,ifdatasubmission
iswaivedorexempted,thereasonsshallbeprovidedindetail.
(3)Ingeneral,fordataprovidedfromoveras,asummarywritteninKorean(excerptofmaincontents)andthe
ecessary,thecompletetranslationoftheentiredocument(signedbya
responsiblepersonwithexpertiinmedicineandpharmacy)mayberequested.
Article23(TypesofDataforSafetyandEfficacyEvaluation)
DatarequiredforsafetyandefficacyevaluationpursuanttoArticles4(1)and9(1)oftheRulesontheSafetyof
Drugs,easfollows:
ordiscovery,andhistoryofdevelopment;
icationsandtestmethods;
data(long-termstabilitydataoracceleratedtestdata);
tydata
(a)Singledotoxicitydata
(b)Multipledotoxicitydata
(c)Reproductiveanddevelopmentaltoxicitydata
(d)Genotoxicitystudydata
(e)Immunologicaltoxicitydata(includingskinnsitizationdata)
(f)Carcinogenicitydata
(g)Localtoxicitydata
tingdataforindications(efficacyandeffects)
uinforeigncountries
milardomesticproducts.
17
Article24(ScopeofDataSubmissionforSafetyandEfficacyevaluation)
(1)Thescopeofdatasubmissionforsafetyandefficacyevaluationdependingonthetypesandnatureofquasi-drugsis
describedinAppendix3.
(2)Forquasi-drugsfallingunderArticle2,subparagraph7(a)ofthePharmaceuticalAffairsAct,toxicitydatamaybe
waivediftheyaresoldintwoormorecountries;however,forproductscontainingnewmaterials,toxicitydatashall
beprovidedpursuanttoparagraph(1).
(3)FornewadditivesspecifiedinArticle21(2)1,thefollowingdatashallbeprovided:
anddiscovery(includingdataonthepurpoofmixingandintendedu)
ochemicalcharacteristicsandspecifications
data(dataonfinishedproductsarealsoacceptable)
tydata(forprervativesandtarcolorants,datashallbeprovidedinaccordancewithrequirementson
attachmentsfornewdrugsspecifiedintheRegulationsonApproval,Notification,
othercas,singledotoxicity,multipledotoxicity,andothernecessarytoxicitydata(localtoxicitydata,skin
nsitizationdata,etc.)shallbesubmitted.);however,itisnotappliedforflavoringagents.
(4)ForexcipientstoinhalableproductspursuanttoArticle21(2)4,thefollowingdatashallbeprovided:
anddiscovery(includingdataonthepurpoofmixingandintendedu)
ochemicalcharacteristicsandspecifications
data(dataonfinishedproductsarealsoacceptable)
tydata(singledoinhalationtoxicity,multipledoinhalationtoxicity,andothernecessarytoxicitydata
(localtoxicitydata,skinnsitizationdata,etc.)shallbeprovided.).However,forrawmaterialsthatdonotfall
underArticle21(2)1,toxicitydataotherthaninhalationtoxicitydatamaybewaived..
Article25(DataRequirementsforSafetyandEfficacyevaluation)
(1)Datarequirementsforsafetyandefficacyevaluationofquasi-drugsshallbeasfollows:
ordiscoveryandhistoryofdevelopment:
DataclearlydescribedaccordingtothefiveWsandoneH(5W1H)principlestohelpjudgmentoftheproduct(e.g.:
when,where,whoextracted,paratedfromwhatorsynthesized;theoriginofdiscovery;whenandwhere
preliminarytestingorclinicaltrial,,etc.)
icationsandtestmethods
Specificationsandtestmethodsudtoidentifythelevelofqualityandspecificationsoftheproductsubjectto
evaluation,ortheresultsofreviewofspecificationsandtestmethods
itydata
(a)Generalrequirements
1)Ingeneral,dataobtainedfromteststhataredomesticallyconductedinaccordancewiththeStandardsforDrug
StabilityTest(MFDSNotice),shallbeprovidedwithrawdata(tiondata
maybeprovided,instead).However,ifdataontainedfromfurtherstudiesperformedincompliancewiththe
StandardsforStabilityStudiesofMedicinesandOtherProductsareadditionallysubmitted,theymaybe
regardedasthosubmittedatthetimeofapplication.
2)Notwithstandingtheprovisionsoftheabove1),stabilitydatageneratedinforeigncountriesmaybeacceptable,
18
providedthatreviewofsuchdataindicatesthatstabilityoftheproductiscured.
(b)Subjectsfortest
1)Quasi-drugscontainingnewsubstances:Periodofushallbeestablishedbadonlong-termstabilitydata,
butifthereisnosignificantchangesuchascontenttc.,periodofumaybeestablishedwithin36monthson
thebasisofacceleratedtestdataconductedfor6months.
2)Quasi-drugsbesides1):Periodofuforitemsthatbeenapprovedornotifiedmayapplywithoutadditional
safetydata,andinthisca,soappliedtorevisions.
tydata
(a)Generalrequirements:DataobtainedfromtestsperformedinaccordancewiththeGoodLaboratoryPractices
(GLP)(MFDSNotice)
(b)Testmethods:DataincompliancewiththeStandardsforDrugToxicityTest(MFDSNotice),ordatashowingthat
thespecificationsandtestmethodsarejustifiablescientificallyandreasonable.
(c)Evaluation
1)Immunotoxicitydata:Thisdatamaybewaivedifthereisnoabnormalreactionfoundasaresultofrepeated
dotoxicitytest.
2)Carcinogenicitydata
a)Carcinogenicitytestdatashallbesubmittedintheanyofthefollowingcas:
(1)Quasi-drugswithcarcinogenicpotential:Ifthechemicalstructureorabiologicalactivityofthequasi-drug
oritsmetaboliteissimilartoasubstanceknowntobecarcinogenic,oraquasi-drugsuspectedtobe
carcinogenicconsideringtheresultsofmultipledotoxicitytestoragenotoxicitystudy.
(2)Quasi-drugsthatareudclinicallyforalongperiodoftime:Inmostcas,over6months.
3)Localtoxicitydata:Forquasi-drugsdirectlyappliedonskinormucousmembraneoreasilyappliedtoskinor
mucousmembrane,r,localtoxicitydatamaybeconductedaspartofothertoxicity
tests.
tingdataforindications(efficacyandeffects)
thepharmacologicalaction
(a)Generalrequirements
Oneofthefollowingshallbeprovided:
1)DataobtainedfromtestsperformedattestinglaboratoriessuchasauniversityorrearchinstitutioninKorea
tashallbeissuedbytheheadoftheorganizationandacceptedasvalid(inthis
ca,summaryoffacilitiesintherearchorganization,rearchstaffandrelevantexperiencesoftesters,etc.
shallbedescribed.)
2)Allpharmatashallbe
notarizedorrecognizedassubmittedorapprovedbytheauthoritythatgrantedapproval,receivednotification
oftheproduct,orregistrationauthority.
3)DatapublishedinanacademicjournalregisteredintheScienceCitationIndex.
(b)Testmethod
Innon-clinicaldata,r,dependingon
thetype,bioaccessibility,est,differentroutesofadministrationmaybeemployed,
19
isimpossibleornotmeaningfultocarryoutanon-clinicaltrial,clinicaltrialdatamaybeprovided,instead:
1)Efficacydata:dataonthepharmacologicalactionsrelatedtotheeffectivenessincludingtheefficacysubject
taalsocontainsthemechanismofactionfortheappearanceof
effectiveness.
2)Pharmacologicaldata
a)Generalpharmacologicaldata(safetypharmacologicaldatamaybeprovided,instead):datathatcomplywith
theGuidelinesforGeneralPharmacologicalTestofDrugs,etc.(MFDSNotice)includingtestingresultson
theeffectsoneachbodypart(system)andfunctionxceptfortoxicitytest,efficacytest,andtestingon
absorption,distribution,metabolism,forwhichthetestingmethodsandevaluation
criteria,etc.,arejustifiablescientificallyandrationally.
b)Safetypharmacologydata:Dataforevaluatingthepotentialundesirablepharmacodynamiceffectsofa
quasi-drugonphysiologicalfunctionsinrelationshiptoexposureinthetherapeuticrangeorabove.
c)Absorption,distribution,metabolism,andexcretiondata:Informationincludinganalysisandvalidation
methods.
5-2Clinicaldata
(a)Generalrequirements
1)Domesticclinicaldata:
a)Forproductsforinternaluorinhalablepreparations,clinicaldatashallbeobtainedfromtestsperformed
byaclinicalrearchinstitutiondesignatedbytheMinisterofMFDSandshallcomplywiththeprovisions
oftheKoreaGoodClinicalPractices(KGCP)(MFDSNotice).Revisionstotheprotocolandfinalprotocol,
allbeprovided.
b)Forotherclinicaldata,clinicaltestsshallbeconductedandevaluatedatanacademicinstitutionorother
testinglaboratoriesinKoreaorforeigncountriesunderinstructionandsupervisionbyamedicalspecialistor
apersonwhohasatleast5yearsofrelevanttestingexperienceatarearchinstitution,hospital,orother
htestsshallbemanagedbyaninstitutionalreviewboard(IRB)definedby
Articles7and8oftheKGCPandthedatashallbeissuedbytheheadoftherelevantorganization(summary
oftestingfacilities,keyequipment,rearchstaff,relevantexperiencesofthetestersshalldescribed)
2)Foreignclinicaldata:
a)Clinictashallberecognized
ornotarizedassubmittedtoorapprovedbythegovernment(authoritythatgrantedapprovaloraccepted
notification,orregistrationauthority)oftherelevantcountry.
b)DatapublishedinanacademicjournalregisteredintheScienceCitationIndex;
c)DataobtainedfromtestingregardedasimplementedinaccordancewiththeKGCPbyareliabletesting
organization.
(b)Testmethod,etc.
1)Fornewquasi-drugsunderdevelopmentinKoreanorforeigncountries,testingshallbeconductedpursuantto
nicaldata,testingshallbeconducted
pursuanttotheKGCP.
(c)Numberoftestcas
20
Thenumberoftestsubjectsshallbedeterminedreasonablydependingonthecharacteristicsofquasi-drugs,
clinicaltrialmethods,etc.,andstatisticallyvalidsothatthesafetyandefficacycanbeverifiedaccordingtothe
availableevaluationmethod.
(d)Evaluation
1)Thereshallbeclinicalsignificancewithregardstotherelevantindications,etc.
2)Forsterilizersanddisinfectants,theefficacytestdatamaybeprovidedinsteadoftheclinicaltestresults.
uinforeigncountries
Dataonuofthequasi-drug
datashallcontainupdatedinformationonthedrugsubstancesandtheirquantities(includingsupportingdatafor
theenclodspecifications),indications,dosageandadministration,precautions,etc.;currentuandlistinginthe
drugformulariesofothercountries;andtheactionstakeninrelationtothesafetyandefficacyoftheproduct.
ataoncharacteristicsoftheproduct(comparisonwithsimilardomesticproducts,etc.)
Acomparativetableshallcontaininformationondrugsubstancesandtheirquantities,indications,dosageand
administration,andprecautions,etcoftheproductincomparisonwithotherexistingdrugsandquasi-drugs
(includingimportedproducts)tashallcontaincomparisondataoncharacteristicsand
defectswithregardstothepharmaceuticalefficacy,advereffectsorsafety.
Chapter4ReviewofSpecificationsandTestMethods
Article26
Deleted.
Article27(DescriptionofSpecificationsandTestMethods)
(1)Specificationsandtestmethodsshallbedescribedinaccordancewiththefollowingprinciples:
mat,terms,unitandmarks,cificationsandtestmethodsshallbeconsistentwiththeKorean
Pharmacopoeia.
ationtobedescribedinthespecificationsandtestmethodsshallcomplywithAppendix4onspecifications
andtestMethodsin;however,omissionmaybealloweddependingondosageforms,asappropriate.
icationsandtestmethodsshallbeconsistentwiththegeneralprinciples,generalprovisionsforpreparations,
ctionsongeneraltestingmethods,referencestandards,reagentsandtestsolutions,orean
whereomissionisallowedforthewholeorpartoftestingmethodspursuantto
subparagraph4,thetestingmethodsshallbestatedindetail.
ductsforwhichthetestmethodslistedintheKoreanPharmacopoeia,KoreanPharmaceuticalCodex,
SpecificationsandTestMethodsforQuasi-Drugs,KoreanHerbalCodex,compendiaandotherspecificationsand
testingmethodsnotifiedorrecognizedbytheMinisterofMFDS(hereinafterreferredtoas“MFDS
Specifications”),ca,testmethodsshallbe
describedasfollows:
E.g.:1)Sterilitytest:Thisproductshallbetestedaccordingtothesterilitytestdescribedinthegeneraltest
methodsintheKoreanPharmacopoeia.
E.g.:2)Contenttesting:Thisproductshallbetestedaccordingtotheclau1)quantificationmethodsfor
21
sodiummonofluorophosphate,sodiumfluoride,andsilicadioxidepastedescribedintheSpecificationsand
TestMethodsforQuasi-Drugs.
thodsstatedinthespecificationsandtestmethodsshallbeverifiedbymethodslistedinthe
ImplementationGuidelinesforValidationofAnalysisMethodsforDrugs,oreanPharmacopoeiaorin
compendia,etc.;however,testmethodslistedintheMFDSSpecificationsshallbeexcluded.
eagents,testsolutions,equipment,instruments,referencestandardsorsubstancesforassayareud,the
descriptionofthereagents,testsolutionsshallcontainthepurity,concentrationandmanufacturingmethods,the
descriptionofequipmentshallcontainthetypesandotherinformation,instructionsforu,andthedescriptions
ofreferencestandardsorsubstancesforassay(hereinafterreferredtoas“referencestandard”)shallcontaintheir
gentsharmfultohumansandtheenvironment(ycompound,benzene,
carbontetrachloride,and1,4-dioxane)shallnotbeudwherepossible.
cificationsandtestmethodsshallbeestablishedonthebasisoftheefficacy,stabilityandprocess
validation,roduct.
(2)Thedrugsubstancesandtheirquantities,manufacturingmethod,storageandperiodofu,
specificationsandtestmethodsshallbedescribedinaccordancewiththeprovisionsinArticles9to18.
(3)Forfabric,rubber,orpapersudforsanitarypurpos,thestructuraldiagramsincludingtheshapeandsizeshall
beprovidedifnecessary.
(4)Ifacontainerisudforsolidincticidestoreducetherisksofaccidentalintake,themanufacturingmethods
shallincludethematerialofthecontainer,andastructuraldiagramshallbepreparedparately.
(5)Ifnecessary,relevantliteratures,workingstandards,drugsubstancesud,andspecialreagents,equipment,
strainsandculturemedium,rovidedparately.
(6)Ingeneral,regardingdatafromoveras,asummarywritteninKorean(anexcerptofthemainterms)andthe
ywhennecessary,completetranslationoftheentiredocument(signed
byaconfirmerwhohasanexpertknowledgeinmedicineandpharmacy)mayberequestedtobesubmitted.
Forinformationinforeignlanguages,inprincipal,originaldocumentsandtheirsummaryinKorean(excerpts)shall
r,ifnecessary,theirfulltranslation(signedbyapersonhavingmedicalandpharmaceutical
experti)maybeprovided.
Article28(EstablishmentofCriteria)
(1)Thecontentsorpotencyofrawmaterialsandfinishedproductshallbeindicatedaccordingtotheanyofthe
r,iftherearedifferentcriteriaapprovedbythemanufacturingcountryorcountryoforigin,
orifitisjustifiable,upportingdataareobtainedfromtestingresults,the
criteriamaybeestablishedconsideringtheactualstatisticalvaluefromtestsconductedatleastthreetimesononelot
forthreeormorelotsofsamples.
lcriteria
(a)Rawmaterial:≥99.0%
(b)Finishedproduct:≥90.0%
22
riteria
(a)Fluorinecompoundintoothpastes:90.0%-110.0%
(b)Hydrogenperoxidesolutionintoothpastes,mouthfreshener,teethwhitenerandhairdye:90.0-110.0%
(c)Hormonesinhairloss-preventiveproductsandhairtonic:90.0%-110%
(d)Thioglycolicacidinexternalapplicationsudfordepilatorypurpo:90.0-110%.
(e)Sterilizersanddisinfectants:90.0%-110.0%
(f)Vitamins
1)Vitamincomposites,vitaminsandmetalelementsaddedinverysmallamountstovitamincomposites:90.0%-
150.0%
2)Vitaminderivatives:90.0%-130.0%
(g)Disinfectingandincticidalingredient(includingboosters)indisinfectantsandincticidesforpreventing
infectiousdias:Theircontentsshallbeconsistentwiththefollowingcriteriadependingontheamountsof
activeingredients.
AmountsofactiveingredientCriteria
Solidform,≤2.5%
75.0%-125.0%
Liquidform,≤2.5%
85.0%-115.0%
>2.5%90.0%-110.0%
riteriaforcontentsarenotestablishedbecaucontenttestingfortheactiveingredientisnotpossibleor
necessary,efficacytest,performancetest,oraformulationtest.(e.g.:hair-dyetestingofhaircoloringproducts)
(2)r,othercriteriamaybeestablishedifjustifiable.
Ifthevalidityofsupportingdatacannotbeacknowledgedaccordingtothefollowingclaus1to4,therangeof
upportingdataareobtainedfromtestresults,thecriteriamaybeestablished
consideringtheactualstatisticalvalueobtainedfromtestsconductedatleastthreetimesononelotforthreeormore
lotsofsamples.
:Criteriashallbeestablishedwithin±1.0oftheactualstatisticalvalue.
icgravity:Criteriashallbeestablishedwithin±0.05oftheactualstatisticalvalue.
ationresidue:Theupperlimitoftheactualstatisticalvalueshallbeestablished.
lcontent:Criteriashallbeestablishedforproductsforinternalucontaining4%ormoreethanol,and
shallbe90%ormoreoftheindicatedvalueinthelabelling.
neitytest:CriteriashallbeconsistentwiththeprovisionsoftheKoreanPharmacopoeiaandtheGeneral
TestMethodsbesidestheKoreanPharmacopoeia.
iallimittest:CriteriashallbeestablishedincompliancewiththeGeneralTestMethodsbesidestheKorean
Pharmacopoeia.
tionindex:Criteriashallbewithin±0.05oftheactualstatisticalvalue.
ontest:stingisperformedaccordingtothe
ctionforanadhesivebandageintheKoreanPharmacopoeia,theadhesivestrengthshallbe150gormoreper
23
widthof12mmforsyntheticresinfilmandfeltbandage.
citytest:stingisperformedaccordingtothe
ctionforanadhesivebandageintheKoreanPharmacopoeia,theadhesivestrengthshallbe1kgormoreper
widthof12mmforsyntheticresinfilmandfeltbandage.
est:Criteriashallbeestablishedforadhesivebandagesincompliancewiththeshapetestsinthection
r,fordisposablebandages,thelengthofthepad
(gauzeorfelt,etc.)shallbenolessthan98.0%oftheindicatedvalue,andthewidthshallbenolessthan94.0%
oftheindicatedvalueinthelabelling.
vativecontenttest:Criteriashallbeestablishedforproductsforinternaluamongquasi-drugs
cas,prervativescontainedintheproductshallbeidentified,andtheamount
shallbe80.0%-120.0%ssary,theparatecriteriamaybedefined.
llectionefficiencytest:stingisperformed
pursuanttoArticle30(4)14,dustcollectionefficiencyshallbenolessthan80.0%forKF80(sodiumchloride
test),nolessthan94.0%forKF94(sodiumchlorideandparaffinoiltests),andnolessthan99.0%forKF99
(sodiumchlorideandparaffinoiltests).
inhalationresistancetest:gisperformedpursuantto
Article30(4)15,facialinhalationresistanceshallbe6.2mmH
2
OorlessforKF80,7.2mmH
2
OorlessforKF94,
and10.3mmH
2
OorlessforKF99.
Article29(DescriptionGuidelinesforSpecificationsandTestMethodsofRawMaterials)
(1)EnclodspecificationsofrawmaterialsshallbedescribedaccordingtoAppendix5onExampleofEnclod
SpecificationsforRawMaterials.
(2)Intheenclodspecificationsintheaboveparagraph(1),necessaryinformationspecifiedinthefollowing
paragraph(3)shallbedescribedtoensureproperqualitycontrolofdrugsubstancesonthebasisofdatasubmittedfor
nformationmaybeprovided,ifnecessary.
(3)Theenclodspecificationsofrawmaterialsshallbedescribedinthefollowingorder:
(a)TheKoreannamesofrawmaterialsshallbeindicatedpursuanttoArticle9(3)andtherelevantguidelineson
drugsnamesdefinedbytheMinisterofMFDS.
(b)TheEnglishnamesofrawmaterialsshallbeindicatedinaccordancewiththeInternationalNonproprietary
NamesforPharmaceuticalSubstances(INNPS)andpursuanttotherelevantguidelinesondrugnamesdefinedby
theMinisterofMFDS.
ural(orrational)formula
Structural(orrational)formulashallbestatedfollowingtheexamplesofdescriptionofthestructural(orrational)
formulasinthePharmacopoeia.
larformulaandmolecularweight
Molecularformulaandmolecularweightshallbedescribedinlinewiththerelevantprovisionsinthe
Pharmacopoeia.
andmanufacturingmethod
24
Theoriginandmanufacturingmethodmaybeomittedforsyntheticproductsofwhichthechemicalstructuresare
,thisinformationshallbestatedforproteinororganextracts(hydrolysis),enzymes,r,
formaterialscontainingatleasttwocompoundsofsimilarstructuressuchastheoptical,geometricstereoisomer,
highpolymer,etc.,itmaybediffi
thisca,theirratioshallbestated.
ition
Thecontent,thismaybeomittedif
thereisaclearreasonwhysuchcriteriacannotbeestablished.
(a)Thecontentsshallbeindicatedinpercentage(%),andthemolecularformulashallbestatedintheparenthesis;
however,ifitisnotappropriatetoindicatethecontentsinpercentage(%),itmaybeindicatedaspotency,unit,etc.
Ifnotpossibletodescribethecontentsoftheingredients,thecontentsofpurechemicalsubstancesmaybe
indicated(e.g.:magnesiumsilicate).
(b)Theupperandlowerlimitsshallbeestablished,inprinciple,andforunstabledrugsubstances,therangeof
suchlimitsshallbeestablishedonthebasisoftheinformationonthesafetyoftheirdecompodmaterials.
ance
Appearanceshandshapearekey
ecessarycriteriashallbeestablishedandstated
inthectionsofthephysicochemicalpropertiesandpuritytest:
(a)Color,shape,smell,taste,estated;however,ifthesmellandtastemayaffectthehealthoftesters,
suchinformationshallnotbestated.
(b)Forsolubility,informationonwater,ethanol,,howpHaffectsthesolubilityshall
bestated,andthesolventudintestingalsoshallbeestablished.
(c)Liquidity,stability(hygroscopicproperty,lightstability,etc.),estated.
ficationtest
(a)Foridentificationtest,colorreaction,precipitationreaction,decompositionreaction,derivativeformation
reaction,infrared/visible/ultravioletspectrum,specialreaction,qualitativereaction,tiveandnegative
ions,estatedwithaspecificfocusonochemicaltestsonthebasisofthechemicalpropertiesofdrug
ecessaryinformationmaybeomitted.
(b)Specifictestingmetestingmethod
isonlytoidentifytheretentiontimeinchromatography,itshallnotbeconsideredasbeingspecific;however,it
mayberecognizedasspecific,ifadetectorthatmayidentifythespecificityisud.
(c)Forsodiumdrugsubstances,atestingmethodthatcandetectsodiumshallbeincluded.
(d)Fordrugsubstancesthatmaybeidentifiedinothertestsbesidesidentificationtest,suchinformationmaybe
quotedinthectionofidentificationtest.
ochemicalproperties
Inordertoindicatethenatureandpurityofdrugsubstances,necessaryinformationshallbeestablishedandstated
followingthedefinitioninsubparagraph(a):
(a)Wholenumbersthataremeasuredbyphysicalorchemicalmethodssuchastherefractionindex,saponification
value,unsaponifiablematters,specificopticalrotation,boilingpoint,specificgravity,acidvalue,hydroxylvalue,
25
estervalue,iodinevalue,meltingpoint,freezingpoint,viscosity,freezingpointoffattyacids,pH,opticaldensity,
etc.
(b)MeasurementofphysicochemicalpropertiesofacompoundshallfollowthegeneraltestmethodoftheKorean
Pharmacopoeiaandshallstatethestandardvalues(e.g.:pH3.0-5.0);however,forthetestsforwhichdetailsare
tobestatedineacharticle,eareatleasttwotestmethodsordevices,the
namesofthetestmethodsordevicesshallbestatedtogetherwiththenamesoftestmethodsinthePharmacopoeia.
(c)Ifatestingmethodspecifiedinacompendiumisud,thenamesofthecompendiumandthetestmethodshall
etailsaretobestatedineacharticle,oriftherearetwoormoretestmethodsor
devices,namesofthetestmethodsordevicesshallbestatedalongwiththestandardvalues.
(d)IfnotlistedintheKoreanPharmacopoeiaorcompendiatestmethodshallbestatedwithstandardvalues.
(e)Physicochemicalpropertiesthatneednotbethestandardsofdeterminingsuitabilityofqualityofproductsshall
bestatedunderthectionofAppearance.
test
(a)Puritytestshallbestatedintheorderofcolor;smell;taste;dissolutionstatus;liquidity;acidoralkali;mineral
salt(sulphate,chlorides,nitrates);ammonium;heavymetal;metal(zinc,iron,etc.);arnic;organicmatter;
generalforeignsubstances(referringtoimpuritiesthatcangetmixed,remained,createdoradded);evaporation
residue;startingmaterial,intermediatematerial,andbyproductthatexistduetoimpurities;decompositionproduct
(hereinafterreferredtoas“flexiblematerial”);otheradulteratedsubstances(isomer,residualsolvent,etc.);and
ecessaryitemsshallbeexcluded.
(b)Dissolutionstatusshallbeestablishedandstatedifitispossibletodeterminethepurityofdrugsubstances.
(c)Formineralsalt,heavymetal,andarnic,necessaryitemsshallbeestablishedandstatedbytakinginto
considerationthemanufacturingprocedure,usagedirectionsanddo,etc.
(d)Forflexiblematerials,thelimitshallbeestablishedandindicatedasapercentage(%)ofthedrugsubstancesor
tisconductedbyusingaliquid
chromatographyoragaschromatographyinsteadofusingareferencestandardofflexiblematerials,measurement
rangeforareas,quantitativelimit,andamethodforverifyingflexiblematerials(vepeakduration)shall
bestated.
(e)Fordrugsubstancesfromwhichisomersareparated,unintendedisomersshallbeestablishedandstated.
(f)Residualsolventshallbeestablishedandstatedregardingthesolventsthathavebeenudduringthe
manufacturingprocessaccordingtothedatasubmittedpursuanttoArticles46through48andamethodthatis
approvedpursuanttotheGuidelinesofResidualSolventforDrugsintheKoreanPharmacopoeiaorintheofficial
compendium,etc.
drying,lossonignition,andmoisture
Theitemsshallbeestablishedandstatedaccordingtotherelevanttestmethodsinthegeneraltestmethodsofthe
KoreanPharmacopoeia.
onresidue,ashoracid-insolubleash
Theitemsshallbeestablishedandstatedaccordingtotherelevanttestmethodinthegeneraltestmethodofthe
KoreanPharmacopoeia.
ltests
26
Ifitisnecessaryforenzymesandproteinororganextracts(hydrolysis),safetytest,antigenicitytest,andhistamine
testshallbeestablishedandstated.
ests
Othertestshallbeestablishedwhenthereisatestitemotherthantheitemsinsubparagraphs1to12thatisdirectly
relatedtotheevaluationofqualityandcuringsafetyandefficacy.(e.g.:isomerratio,polymorphism,microbial
limittest,particlesizetest)
ficationmethod
Asamethodthatmeasuresthematerial’scontent,unitofcontent,haphysical,chemicalorbiological
method,atestmethodthathasahighaccuracy,precision,andspecificityshallbeestablished;however,inpurity
tests,ifatestmethodthathasahighspecificityofbeingabletosimultaneouslyanalyzetheflexiblematerialsis
beingestablished,itshallbeapprovedevenifthespecificityislow(e.g.:ifatestmethodthatcanparatethe
mainingredientandtheflexibleingredientsimultaneouslyandquantifythemduringapuritytestistasaHPLC,
etc.,atitrationmethodispossibleforquantificationmethods.)
ncestandard,reagentandtestsolution
Whenreferencestandards,reagents,ortestsolutionsnotlistedintheKoreanPharmacopoeiaandcompendaare
ud,therelevantfollowingsubparagraphsshallbestated:
(a)Referencestandardshallestablishspecificationsthatareproperforitspurpo,andapurificationmethod
(includingamanufacturingmethodwhenitisdifficulttoobtainmaterialsotherthanthepertinentdrugsubstances)
erialsforquantificationshallstateamethodthatmeasuresthecontent
throughatestmethodthatisabletomeasuretheabsoluteamount.
(b)Ingeneral,contentofreferencestandardshallbenolessthan99.0%.
(c)Reagentandtestsolutionshallstatepreparationmethods.
emethod
StoragemethodshallbestatedpursuanttoArticle16.
(4)StatingmanufacturingmethodsofdrugsubstancesshallcomplywithArticle11.
Article30(DescriptionGuidelinesforStandardsandTestMethodsofFinishedProducts)
(1)Standardsandtestmethodsoffinishedproductsshallbewrittenparatelyforstandardsandtestmethods
followingtheExampleofCompletedStandardsandTestMethodsinAppendix6,buttheitemstobelistedfor
standardsandtestmethodsandtheirordershalleachbethesame.
(2)Itemstobelistedforthestandardsandtestmethodsshallincludeitemsfromtheitemslistedinparagraphs(3)and
(4)thatareneededforprovidingreasonablenessinqualitycontrolofquasi-drugsbadonthedatasubmittedforthe
temsmaybeaddedifnecessary.
(3)Standardsshallbewritteninthefollowingorder:
ance
AppearanceshallbewrittenpursuanttoArticle10.
ficationtest
Forallactiveingredients(includingthebooster),itshallbestatedthat“itshallbeappropriatetoatestconducted
accordingtotheconfirmationtestmethodforOOO(nameoftheingredient).”However,ifthereisaclearreason
27
fornotbeingabletotupaconfirmationtest,thismaybeomitted.
ochemicalproperties
Regardingtheitemsforthephysicochemicalpropertyofdrugsubstances,itemsthataredirectlyrelatedwiththe
qualitycontrol,safety,andefficacyoffinishedproductsshallbeestablished(e.g.,pH,specificgravity,
liquidproducts,etc.)andtheirvaluesshallbelisted.
test
Limitsfortheactiveingredientortheunitdosageformofafinishedproductshallbeestablishedandstatedin
percentage(%),mass,ideringthedatatobesubmittedpursuanttoArticles31and32andthefollowing
subparagraphs(a)and(b)andshalleachbecategorizedintoindividualflexiblematerialsofwhichthestructureis
established,otherflexiblematerials,andtheentireflexiblematerials.
(a)Amongfinishedproducts,necessaryitemssuchastheflexiblematerial,reagent,catalyst,heavymetal,mineralsalt,
solvent,veapossibilityofgettingmixedshallbeestablished.
(b)Limitsshallbeestablishedwhenachangeixpectedduringtheprocessofformulatingproductsorduringthe
storage.
dryingormoisture
Valuesshallbestatedinpercentage(%),assofthefinishedproduct.
ationtest
Formulationtestitemsthatarenecessaryfordefiningcharacteristicsorfunctionsofproductsshallbeestablished.
ests
OthertestsshallbedescribedaccordingtotheothertestsitempursuanttoArticle29(3)13.
ttest
Amountorpotencyindicatedofallactiveingredientsshallbewritteninpercentage(%).Inadditiontothenameof
mainingredients,molecularformulaandmolecularweightshallbewrittenintheparenthes.(E.g.,Whentesting
iscarriedoutaccordingtothefollowingtestmethod,atleast90.0%oftheamountindicatedforOOO(molecular
formula:molecularweight)shallbecontained.)
(a)Fortoothpastes,thecontentcriteriaforactiveingredientsincludingabrasivesandanti-plaquesshallbe
established.
(b)Forincticides,thecontentcriteriaforactiveingredientsincludingboostersshallbeestablished..
(c)Forhaircoloringproducts,hair-dyingtestmaybeconductedinsteadofthecontenttest.
teriaforprervativesshallbeestablishedonlyfortheproductsforinternalufallingundersubparagraph
2(h)oftheDesignationoftheScopeofQuasi-Drugs(MFDSNotice),andtheyshallbeindicatedinpercentage
(%)tiontothenamesofprervatives,molecularformulaand
molecularweightshallbeindicatedintheparenthes.(E.g.,Whentestingiscarriedoutaccordingtothe
followingtestmethod,OOO(molecularformula:molecularweight)shallbeidentifiedandshallbe80.0%-120.0%
oftheamountindicated.)
-dyingtest
Thisitemshallbeestablishedonlyforhairdyeproducts,anditshallstatethat“itshallbeappropriatetoatest
conductedaccordingtothefollowingtestmethod.”
vestrengthtestforband-aids
28
Intheadhesivestrengthtestforband-aids,itshallbestatedthat“whentestingiscarriedoutaccordingtothe
followingtestmethod,itshallbeatleastOOO(gorN,etc.)/OOOmm.”
citytestforband-aids
Intheelasticitytestforband-aids,itshallbestatedthat“whentestingiscarriedoutaccordingtothefollowingtest
method,itshallbeatleastOOO(kgorN,etc.)/OOOmm.”
estforband-aids
Intheshapetestforband-aids,itshallbestatedthat“whentestingiscarriedoutaccordingtothefollowingtest
method,thelengthshallbeatleast98.0%oftheindicatedlength,andthewidthshallbeatleast94.0%ofthe
indicatedwidth.”
llectionefficiencytest
Dustcollectionefficiencytestshallbeestablishedonlyforsanitarymasks,anditshallbestatedthat“whentesting
iscarriedoutaccordingtothefollowingtestmethod,eachindividualmeasurementvalueshallbenolessthan
OOO%.”
(4)Testmethodsshallbedescribedinthefollowingorder:
ance
Testmethodsthatutilizensshallbementioned.(e.g.:visuallyobrve)
ficationtest
Ingeneral,identificationtestsshallbewrittenforallactiveingredients,mostlyfocusingonchemicaltests,
htestingmethodcanparateandidentifyeach
activeingredient.
ochemicalproperties
(a)IfgeneraltestmethodsintheKoreanPharmacopoeiaandcompendiaareud,theKoreanPharmacopoeiaand
ilsaresuppodtobestatedin
eachArticle,ortherearetwoortestmethodsordevices,thenameofthetestmethodorthedeviceshallbestated.
Ifaprioroperationisnecessary,itshallbestated.
(b)FortestmethodsnotlistedintheKoreanPharmacopoeiaorcompendia,testmethodsshallbedescribedin
detail.
test
(a)Ifitisnecessarytoquantifythematerial,testmethodconsideringtheprecision,accuracy,specificity,limitof
quantification,linearity,andrangeshallbestated,andifquantificationisnotnecessary,testmethodconsidering
specificityandlimitofdetectionshallbestated.
(b)Ifareferencestandardofflexiblematerialisnotudandatestisconductedusingliquidchromatographyor
gaschromatography,amethodthatcanidentifythemeasurementrangeforareas,limitofquantification,and
flexiblematerialsshallbestated(e.g.,relativepeakholdingtime).
dryingormoisture
TestmethodintheKoreanPharmacopoeiashallbefollowed,andthedetailsshallbestated.
ationtest
(a)FortestmethodsspecifiedintheKoreanPharmacopoeiaandcompendia,theKoreanPharmacopoeia,nameof
thecompendium,ssary,thedetailsshallbestated.
29
(b)FortestmethodsnotlistedintheKoreanPharmacopoeiaorcompendia,detailsshallbestated.
ests
OthertestsshallbedescribedaccordingtotheothertestspursuanttoArticle29(3)13.
ttest
(a)Testmethodthatconsidersprecision,accuracy,specificity,linearity,andrangeshallbepreparedandstated.
(b)Iftherearetwoormoreactiveingredients,testmethodforeachingredientshallbestated;however,ifthetests
canbecarriedoutsimultaneously,theymaybestatedtogether.
vative
TheGeneralTestMethodsNotListedintheKoreanPharmacopoeiashallbefollowed;however,forprervatives
notincludedinthisNoticeorifthesupportingdatashallbesubmittedregardingthetestmethod,testmethodshall
bewrittenparately.
-dyingtest
Followingdetailsshallbestated:
DepositawhiteclothorwoolinahairdyesolutionthathasbeenmixedinaratiostatedintheUsageDirections
eavingitunattendedfor20-30minat25℃,washwithwaterandletitdry;however,ifthe
processingtemperatureandtimearedifferentfromtheconditionsabove,dosageandadministrationshallbe
followed.
vestrengthtestforband-aids
Followingdetailsshallbestated:
Testingshallbeconductedaccordingtotheadhesivestrengthtestforband-aidsintheKoreanPharmacopoeia;
however,fordisposableband-aids,testshallbeconductedaccordingtotheadhesivestrengthtestforband-aids
(disposable)intheStandardsandTestMethodsforQuasi-Drugs.
citytestforband-aids
Followingdetailsshallbestated:
Testingshallbeconductedaccordingtotheelasticitytestforband-aidsintheKoreanPharmacopoeia;however,
fordisposableband-aids,testshallbeconductedaccordingtotheelasticitytestforband-aids(disposable)inthe
StandardsandTestMethodsforQuasi-Drugs.
estforband-aids
Followingdetailsshallbestated:
Testingshallbeconductedaccordingtotheshapetestforband-aidsintheKoreanPharmacopoeia;however,for
disposableband-aids,gauzeshallbetestedaccordingtothegauzecategoryinthePharmacopoeia.
llectionefficiencytest
Followingdetailsshallbestated:
(a)Testshallbecarriedoutusingasodiumchloride(NaCl)aerosolaccordingtothefollowingtestmethod:
Withsixspecimens,threeshallbeastheyaresubmitted,andtheotherthreeshallbeleftunattendedat
temperature38±2.5℃andhumidity85±5%RHfor24±
makingasodiumchloridesolution,sodiumchlorideaerosolshallbecreatedusinganautomaticfiltertesting
areashallbeplacedintheautomaticfiltertestingdevice,andthesodiumchlorideaerosolshallbe
trationshallbemeasuredbeforeandafterthe
30
aerosolissprayedonthefacialarea,andotherdetailsofthetestmethodshallbewrittenindetail.
(b)Testshallbecarriedoutusingaparaffinoilmistaccordingtothefollowingtestmethod.
Withsixspecimens,threeshallbeastheyaresubmitted,andtheotherthreeshallbeleftunattendedat
temperature38±2.5℃andhumidity85±5%RHfor24±inoil
areashallbeplacedintheautomaticfilter
testingdevice,andtheparaffinoilmistshallbesprayedthroughthefacialareaataflowof95Lperminute.
Concentrationshallbemeasuredbeforeandafterthemistissprayedonthefacialarea,andotherdetailsofthe
testmethodshallbepreparedandwrittenindetail.
inhalationresistancetestforsanitarymasks
Followingdetailsshallbestated:
Testsxsanitarymasks,three
shallbeastheyaresubmitted,andtheotherthreeshallbeleftunattendedattemperature38±2.5℃andhumidity
85±5%RHfor24±olumnshallbemeasured(mmH
2
O)asair
issprayedthroughthefacialareaatacontinuousflowof30Lperminute,andotherdetailsofthetestmethod
shallbewrittenindetail.
(5)Referencestandard,reagent,andtestsolution
Relevantitemsshallbedescribedpursuanttothereferencestandard,reagent,andtestsolutionctionsinArticle29
(3)15.
Article31(TypesandScopeofSubmissionofDataforEvaluationofStandardsandTestMethods)
(1)Thetypesofdatatobesubmittedfortheevaluationofstandardsandtestmethodsshallbeasfollows,andthe
scopeofsubmissionofdatafortheevaluationofstandardsandtestmethodsbadonthecharacteristicsofeach
quasi-drugshallbeasshowninAppendix7:
ordiscoveryandhistoryofdevelopment
uraldetermination,physicochemicalcharacteristics,andbiologicalcharacteristics(productqualitydata)
(a)Rawmaterials
1)Structuraldetermination
2)Physicochemicalcharacteristicsandbiologicalcharacteristics
3)Manufacturingmethods
4)Standardsandtestmethods
5)Supportingdataforstandardsandtestmethods
6)Testresults
7)Referencestandards,reagents,andtestsolutions
8)Containersandpackaging
(b)Finishedproduct
1)Drugsubstancesandtheirquantities
2)Manufacturingmethods
3)Standardsandtestmethods
4)Supportingdataforstandardsandtestmethods
31
5)Dataabouttestreports
6)Dataaboutreferencestandard,reagent,andtestsolution
7)Dataaboutcontainersandpackaging
asusagestatusdata
ativereviewwithsimilardomesticproductsandcharacteristicsofapertinentquasi-drug,etc.
(2)Forrawmaterialsthathavebeenmanufacturedthroughanextractionandforfinishedproducts,reasonsfor
lectingasolvent,etc.,dataaboutthebasisforlectingdrugsubstancesandtheamount,esubmittedas
flowofallmanufacturingprocessandtheusageamount,yield,
drugsubstancesshallbestatedindetail.
(3)Notwithstandingparagraph(1),ifdatahavebeensubmittedforthesafetyandefficacyevaluationorifthedata
havebeensubmittedsimultaneously,suchfactshallbestatedinthesubmitteddata,anddatashallnotbesubmitted.
Article32(RequirementsofDataforEvaluationofStandardsandTestmethods)
(1)Requirementsofdataforevaluationofstandardsandtestmethodsforquasi-drugsshallbeasfollows:
ordiscoveryandthedevelopment
DatathatareclearlywrittenaccordingtothefiveWsandoneH(5W1H)principleforaidinginmakingajudgment
aboutthepertinentquasi-drugs(e.g.:who,whenwhere,whatwithregardstotheextraction,parationorsynthesis;
whatwastheoriginofdiscovery;whenandwheredidtheprimarytesting,clinicaltrials,,etc.)
outstructuraldetermination,physicochemical,andbiologicalcharacteristics(productqualitydata)
(a)Generalinformation
1)Dataaboutstructuraldeterminationandphysicochemicalcharacteristicsinwhichtheorigin,intrinsic
characteristics,composition,manufacturingmethod,contentstandardsofactiveingredients,puritytest(content
standards,vymetalssuchasarnic,etc.),inalrawmaterialspecifications–amatterthat
isrelatedtothereviewofsafety,efficacy,andstandardsandtestmethods,whichaidinmakingajudgment
aboutthebasicrequirementsasquasi-drugs–arestated;dataaboutbiologicalcharacteristicsinwhich
biologicalvitality,content,purity,ted;anddataaboutstandardsandtestmethodsthatcanverify
thequalitylevel,specifications,temssubjecttoreview.
2)Basisforestablishingstandardsshallincludespecificdataaboutactualmeasurements,actualmeasurement
statistics,safetytestresult,andconsiderations,ningthesafetyandefficacy.
3)Actualmeasurementsshallsubmitdatafornolessthanthreetimesperlotforspecimenswhichreprentat
sultstobeexpresdinvaluesshall
besubmittedwithspecificvalues,andstatisticalmethodsandactualmeasurementstatisticsudforcollection
ofspecimenandprocessingofactualmeasurementsshallbesubmitted.
(b)Rawmaterialdata
1)Structuraldeterminationdata
a)Datathatverifythechemicalstructureofmainingredients
(1)Dataaboutrawmaterials,solvent,purificationmethod,erelatedtotheestablishmentofitemsfor
thesynthesispathdiagramwithsynthesismethodandthepuritytest
(2)Datarelatedtoandtheconsiderationofthecharacteristicsofchemicalstructuressuchastheanalysisof
32
element,ultraviolet-visibleabsorptionspectrum,infraredspectrum,nuclearmagneticresonancespectrum,
massspectrum,etc.
(3)Chemicaldataaboutstructuraldetermination(derivatization,etc.)anditsconsideration
(4)Incaofopticalisomers,etc.,dataabouttheirthree-dimensionalstructure
b)Drugsubstancesofwhichthecompositionofmainingredientsarenotclear,suchaspolymers,etc.,shall
preferablysubmitdataaboutphysicochemicalcharacteristicsanddatathatcanverifythatquasi-drugswitha
homogeneouscompositionorpotencyareproducedthroughamanufacturingprocess.
2)Dataaboutphysicalandchemicalcharacteristics:physicochemicalcharacteristicsofmainingredientsshall
submitdatathatcanbecomeabasisforestablishingtestitemsofstandardsandtestmethodsandshallinclude
dataaboutactualmeasurements.
a)Appearance:dataforcolor,shape,taste,etc.
b)Solubility:solubilitydatathataredeterminedbadontheconcentrationofasaturatedsolution
c)Hygroscopicproperty
d)pHofthesolution
e)Meltingpoint(includingthedecompositionstatus)andthermalanalysisvalue
f)Dissociationconstant
g)Partitioncoefficientanddistributionratio:octanol-water,ioncoefficient,partitioncoefficientshall
bedatathatcontaintheinfluenceofpH.
h)Polymorphism:asdataaboutthepolymorphismstatus,mutualrelationshipbetweencrystalforms,physical
characteristicsabouteachcrystalforms,etc.,datasuchastheinfraredspectrometermeasurements,thermal
analysis,particlex-raydiffraction,etc.
i)Angleofrotation:statusorrotarypolarization,iftherotarypolarizationisverified,dataabouttheinfluenceof
themeasurementsolvent
j)Isomer(Opticalisomer,etc.):iftherawmaterialisamixtureofisomersuchastheopticalisomer,etc.,data
abouttheparationandanalyticalmethodofisomersandtheisomerratio.
k)Others:ifthereareotherresultsfromareviewofmaterialproperty,etc.,relevantdata
3)Dataaboutmanufacturingmethods
ItshallcomplywiththerequirementsofmanufacturingmethodsofrawmaterialspursuanttoArticle11.
4)Datainwhichstandardsandtestmethodsarestated
5)Evidentiarydataaboutstandardsandtestmethods
a)Asanevidentiarydataforestablishingspecifications,foreachtestitem,dataaboutthetestmethod,reasons
forlectingthetestmethod,reasonsforestablishingtestconditions,validationoftestmethods,actual
measurements,evidenceofestablishingstandardvalues,calculations,examples,eincluded.
b)Puritytestdata
(1)Generalinformation
ementstatistics
Limitsthathavebeenestablishedshallprovidereasonablebasisbyconsideringtheactualmeasurement
statistics,resultsofveretestsandlong-termstoragetestamongthesafetytest,andthesafety.
lotsudinthesafetytestandclinicaltrialsandthelotsthatreflecttheactualproductionprocess,
33
amountofflexiblematerialsincludingthematerialsofunknownchemicalstructuresandtheanalytical
methodshallbestatedandsubmitted.
estamongtestmethodsshallsubmitaverificationdataaboutthespecificity(includingthe
abundanceandrecoveryratenearthelimitvalues)tativetestmethodshall
submitarison,test
methodsthatmeasureflexiblematerialsshallsubmitdatathatcomparensitivitiesofmaterialsudasa
referencestandardandnsitivitiesofflexiblematerials.
(2)Inthefollowingcas,dataaboutflexiblematerialsshallbesubmitted:
wmaterialswhodailymaximumadministereddoisnogreaterthan2gaccordingtothe
calculationcarriedoutwithusagedirectionsanddoofapreparationcontainingpertinentrawmaterials,
flexiblematerialsarecontainedinexcessof0.05%.
wmaterialswhodailymaximumadministereddoisnogreaterthan2gaccordingtothe
calculationcarriedoutwithusagedirectionsanddoofapreparationcontainingpertinentrawmaterials,
flexiblematerialsarecontainedinexcessof0.03%.
(3)Inthefollowingcas,dataaboutthechemicalstructureofflexiblematerialsshallbesubmitted:
wmaterialswhodailymaximumadministereddoisnogreaterthan2gaccordingtothe
calculationcarriedoutwithusagedirectionsanddoofapreparationcontainingpertinentrawmaterials,
flexiblematerialsarecontainedinexcessof0.10%oratotaldailyconsumption1.0mg,whicheveris
smaller.
wmaterialswhodailymaximumadministereddoisnogreaterthan2gaccordingtothe
calculationcarriedoutwithusagedirectionsanddoofapreparationcontainingpertinentrawmaterials,
impuritiesarecontainedinexcessof0.05%.
(4)Inthefollowingcas,asdatathatverifythesafety,repeateddotoxicitytestdata(Category1,14-90
days),genotoxicitystudydata(revermutationtest,invitrochromosomeabnormalitytest),andother
necessarytoxicitytestdataincompliancewithArticle23(1)4shallbesubmitted:
ugsubstanceswhodailymaximumadministereddoisnogreaterthan2gaccordingtothe
calculationcarriedoutwithusagedirectionsanddoofapreparationcontainingpertinentdrugsubstances,
flexiblematerialsarecontainedinexcessof0.15%oratotaldailyconsumption1.0mg,whicheveris
smaller.
ugsubstanceswhodailymaximumadministereddoisnogreaterthan2gaccordingtothe
calculationcarriedoutwithusagedirectionsanddoofapreparationcontainingpertinentdrugsubstances,
flexiblematerialsarecontainedinexcessof0.05%.
c)Lossondrying,lossonignition,moisture,andignitionresidue:whendefiningthelossondrying,quasi-drugs
thetestsarenotestablishedbecautheamountis
verysmallamount,etc.,itshallbepreferredthatactualmeasurementsdatabesubmitted.
d)Contenttest:Datashallbesubmittedregardingprecision,accuracy,linearity,andscope,ingtoa
methodthatispubliclyapprovedandincludedintheGuidelinesforValidationofAnalyticalMethodsofDrugs,
oreanPharmacopoeiaorintheofficialcompendium,videntiarydataaboutthevalidity
oftestmethodsshallbesubmitted;however,whenitisnotpossibletoestablishaquantificationmethod,
34
specificreasonsandanevidentiarydatawhichshowsthatitwillnotaffectcuringthequalityofproductshall
besubmitted.
e)Itemsthathavenotbeenestablishedinthestandardsandtestmethodsbutneedareviewshallsubmitthe
result.
6)Dataabouttestreports
Testreportinwhichtestdata,testresults,tedshallbesubmitted.
7)Dataaboutreferencestandard,reagent,andtestsolution
a)ReferencestandardoutsidethePharmacopoeiaandtheofficialcompendiumshallsubmitthepertinent
referencestandardanddataconcerningtheestablishmentofspecifications,tsandtestsolutions
outsidethePharmacopoeiaandtheofficialcompendiumshallsubmitdataconcerningtheirpreparationmethod.
b)Referencestandardshallsubmitdataconcerningthepurificationmethodasnecessary(includinga
manufacturingmethodwhenitisnotadrugsubstanceanddifficulttopurchathematerial).
(c)Finishedproductdata
1)Drugsubstancesandtheamount
Validpurpoofmixing,usage,
theevidentiarydataregardingthespecificationofexcipientsshallbesubmitted.
2)Dataaboutmanufacturingmethods
Dataaboutmanufacturingmethodsshallcomplywiththerequirementsofmanufacturingmethodsforquasi-
drugsinArticle11.
3)Datainwhichstandardsandtestmethodsarestated
4)Evidentiarydataaboutstandardsandtestmethods
a)Standardsandtestmethods
Asdatathatareintendedtoshowthegroundsforestablishingthestandardsandtestmethods,foreachtestitem,
dataaboutthetestmethod,reasonsforlectingthetestmethod,reasonsforestablishingtestconditions,
validationoftestmethods,actualmeasurements,basisforestablishingthestandardvalues,calculations,
examples,eincluded.
b)Puritytestdata
Generalinformationshallcomplywiththepuritytestdataofdrugsubstances.
c)Ingeneral,solidproductsthatareadministeredorallyshallestablishstandardsandtestmethodsfor
dissolutiontestsaccordingtothemethodsthatarepubliclyapprovedandincludedintheGuidelinesfor
EstablishmentofDissolutionSpecificationsofOralDrugsintheKoreanPharmacopoeiaorintheofficial
compendium,di
disintegrationtestistablishedinlieuofadissolutiontest,validreasonsshallbesubmitted.
d)Ifasterilitytestistablished,performancetestdataofaculturemediumandbacterialgrowthinhibitiontest
datadefinedinthePharmacopoeiashallbesubmitted.
e)Contenttestshallcomplywiththecontenttestinsubparagraph2(b)5)d).
f)Liquidelectricmosquitorepellentincenshallsubmitdataaboutfumigationconditionsduringtheusagetime
prescribedintheusagedirectionsanddo.
g)Itemsthathavenotbeenestablishedinthestandardsandtestmethodsbutneedareviewshallsubmitthe
35
result.
5)Dataabouttestreports
Testreportinwhichtestdata,testresult,tedshallbesubmitted.
6)Dataaboutreferencestandard,reagent,andtestsolution
a)ReferencestandardoutsidethePharmacopoeiaandtheofficialcompendiumshallsubmitthepertinent
referencestandardanddataconcerningtheestablishmentofspecifications,tsandtestsolutions
outsidethePharmacopoeiaandtheofficialcompendiumshallsubmitdataconcerningtheirpreparationmethod.
b)Referencestandardshallsubmitdataaboutpurificationmethodsasnecessary(includingamanufacturing
methodwhenitisdifficulttomakeapurchawithmaterialsotherthanthepertinentdrugsubstances).
7)Dataaboutcontainersandpackaging
Selectionofmaterials,protectionfromhumidityandlight,compatibilitybetweentheconstituentsofadirect
containerandthequasi-drugs(includingcontaineradhesion,glass),andthesafetyandperformanceof
constituentmaterialsofadirectcontainershallbestated.
asusagestatusdata
Asdataconcerningtheusagestatusineachcountryforaidinginmakingajudgmentabouttheutilityofapertinent
quasi-drug,datathatcanverifythedateofapprovalofrelea,drugsubstancesandtheamount(includingan
evidentiarydataforspecificationsincaoftheenclodspecifications),efficacyandeffect,usagedirectionsand
do,precautionsforu,storagemethodandperiodofu(validperiod),etc.;datafrominvestigationofusage
statusandlistindrugformularyineachcountry;anddatawhichincludethelatestinformationonthemeasures
takenbyeachcountryinrelationtothesafetyandefficacy.
ativereviewwithsimilardomesticproductsandcharacteristicsofapertinentquasi-drug
Dataincludingacomparativetabletocomparewithexistingquasi-drugs(includingimportedquasi-drugs)ofa
similarefficacyregardingdrugsubstancesandtheiramount,efficacyandeffect,usagedirectionsanddo,
precautionsforu,athatcompareandreviewcharacteristics,defect,harmaceutical
efficacy,sideeffects,safety,esubmitted;however,forherbalsubstancesandherbmedications,listof
herbdrugscodexshallbesubmitted.
(2)Notwithstandingparagraph(1),incticidesshallsubmitapreliminarytestdataandpuritytestdatathathavebeen
preparedaccordingtothestandardsandtestmethodsformainingredients,andliquidelectricmosquitorepellent
incenshallsubmitdataaboutfumigationconditionsduringtheusagetimeprescribedintheusagedirectionsand
do.
Chapter5PermissionandEvaluationofInfectiousDia-PreventiveDisinfectants,
Incticides,etc.
Article33(ScopeofApplication)
ThisChaptershallapplytoproductsthatfallundersubparagraph7ofArticle2ofthePharmaceuticalAffairsAct.
Article34(Processing,ission)
36
(1)TheprovisionsofArticles3through6shallapplymutatismutandistotheprocessingofpermissionofproducts,
processingofrevisions,preparationofapplications,subjectsofpermissions,ectiousdia-preventive
disinfectantsandincticides,cas,“Article7throughArticle18”inArticle4(1)shallbeconsideredas
“Article36throughArticle42.”
(2)IftheDirectoroftheCentersforDiaControlandPreventionrequestsrevisiontomatterspermittedforthe
pertinentproductbadontheresultofimplementinganefficacytestsuchasresistancemonitoring,ent
infectiousdias,theMinisterofMFDSmayorderpermissionofrevisionstoefficacyandeffect,usagedirections
anddo,precautionsforu,nttotheprovisionsofArticle76ofthePharmaceuticalAffairsAct.
Article35(Restriction,ission,etc.)
(1)Ifitisdeemedthatthereislikelytobeariskonhumanandenvironmentbadontherequestbyrelevant
authoritiessuchastheMinisteroftheMinistryofEnvironment,etc.,theMinisterofMFDSmaytakenecessary
measuressuchasarestriction,ission.
(2)Withregardstotheproductsthataresubjecttothesafetyandefficacyevaluation,theMinisterofMFDSshall
impoarestrictiononpermissionforpertinentproductsiftheycorrespondtothefollowing:
estreportofasingledoadministrationtestforinfectiousdia-preventivedisinfectantsand
incticidesisclassifiedtoLevelI(DeadlyToxic)orLevelII(HighlyToxic)accordingtothefollowingtable;
however,ifitisdeterminedthatsafetywouldbecuredforursasaresultofanevaluationthattookinto
considerationthestandarduconcentrationorusageoftheproduct,formofthepreparations,methodofu,etc.,
permissionmaybegranted.
Type
MedianLethalDo(LD
50
,mg/kgBodyWeight)
OralTransdermal
SolidLiquidSolidLiquid
LevelⅠ
(Deadlytoxic)
<5<20<10<40
LevelⅡ
(HighlyToxic)
5–5020–20010-10040-400
LevelⅢ
(Toxic)
50–500200-2,000100-1,000400-4,000
LevelⅣ
(SlightlyToxic)
≥500≥2,000≥1,000≥4,000
rimaryskinirritationindexoftheinfectiousdia-preventivedisinfectantsandincticidesisatleast5.1;
however,ifitisdeterminedthatsafetywouldbecuredforursasaresultofanevaluationthattookinto
considerationthestandarduconcentrationorusageoftheproduct,formofthepreparations,methodofu,etc.,
permissionmaybegranted.
37
cuteocularirritationindexoftheinfectiousdia-preventivedisinfectantsandincticidesisatleast60;
however,ifitisdeterminedthatsafetywouldbecuredforursasaresultofanevaluationthattookinto
considerationthestandarduconcentrationorusageoftheproduct,formofthepreparations,methodofu,etc.,
permissionmaybegranted.
esultofthefishtoxicitytestis1/2LC
50
≤PEC;however,ifLC
50
≤PEC<1/2LC
50
,limitedumaybe
permitted.(PEC,PredictedEnvironmentalConcentration:estimatedconcentrationintheenvironment)
Article36(ProductName,etc.)
(1)TheprovisionsofArticles7through11shallapplymutatismutandistotheguidelinesforwritingctionssuchas
theproductname,classificationnumber,drugsubstanceanditsamount,appearance,andthemethodof
manufacturing;however,ingeneral,amountsofallexcipientsshallbeindicated;however,excipientsaddedinvery
smallamounts,suchasthecoloringagent,fragranceingredients,pHadjuster,viscositymodifierandsolvent,may
state“optimumdo.”
(2)Effectenhancershallbeaddedbadonthesafetyandefficacydata,andtheorganicsolventwhichisudduring
themanufacturingprocessshallnotbeacknowledgedforadirectincticidal,sterilization,anddisinfectioneffect
andshallbesafeintermsofitsusage.
Article37(EfficacyandEffect)
Efficacyandeffectthathavenobasisshallnotbeadmitted,andtheyshallbedescribedinaccordancewiththe
following:
s(extirpation,repellent,disinfection,etc.)onsubjectstowhichthepertinentproductshowsitffect(flies,
mosquitoes,cockroaches,ants,andtheirlarvaorimago,etc.)shallbestated.
sionsthatareinterpretedwithvagueandindefinitemeaningsandtermsthatareexaggerated,excessive,etc.
andthatmaycaumisunderstandingforpeopleshallnotbeud.
cyandeffectofproductsthatfallundertheScopeofSubmissionofData3)inAttachment8ofArticle46
(1)shallcomplywiththemattersthatarealreadypermitted.
Article38(UsageDirectionsandDo)
Usagedirectionsanddoshallbeindicatedasfollows:
a“Donotudirectlytohumanbody.”shallbewrittenfirstbeforeanyotherphra.
possibletocategorizethedilutionmethod,applicationratio,sprayingmethod,etc.,theyshallbe
categorizedandstatedclearly.
Example)
(a)Applicationratio
TargetedharmfulinctDilutionMethodApplicationratio(weight(g)or
volume(mL)/area(m2))
Mosquito150xdilution(Add1Loftheg/OOm2
38
productto149Lofwater,andmix
well.)
(b)Sprayingmethod
(c)LocationandMethodofU
Article39(PrecautionsforU)
Precautionsforushallstateallofthemostrecentmattersrelatedtosafetyandefficacy(includingthematters
concerningexcipients)thatarenecessaryforsafeandreasonableuofinfectiousdia-preventivedisinfectants
andincticides,cas,itemstobe
statedmaybeadjusteddependingonthecharacteristicsofeachpreparation.
alsubstanceslistedinAppendix1ofArticle3oftheDesignationofToxicMaterialsandMaterialsunder
Obrvation(NationalInstituteofEnvironmentalRearchNotice)shallstatematterstobeindicatedfortoxic
materials.
ncymeasures
Firstaidtreatmentincaofcontactingthedrugthroughskin,eyes,inhalation,estated.
CaofApplication)
tionsfortoxicmaterialscontainedinthisquasi-drugareasfollows:
(a)Glutaraldehyde
1)Harmfulrisks
a)Harmfulifswallowed
b)Irritatingtoeyesandskin
c)Maycauhypernsitivityifincontactwithskin
d)Verytoxictoaquaticorganisms
2)Precautionsforu
a)Avoidcontactwithskinandeyes.
b)Incaofcontactwitheyes,rinimmediatelywithplentyofwaterandekmedicaladvice.
c)Avoiddischargingtotheenvironment.
3)Hazardsymbols
E.g.)(1)Incaofcontactwithskin:atelywashwithsoapand
39
lprecautions
(a)Whensprayingtheproduct,
particular,children,niors,patients,riticallyaffected.
(b)Whenusingtheproduct,foodordrinkmaynotbeconsumed,andsmokingisprohibited.
(c)Wearsuitableprotectiveclothing(workingclothesofwhichthetopandbottomareconnected),gloves,eye/face
protection,cas,protectiveclothingshallberegularlywashedparatelyfromordinarylaundry.
(d)Aftercarryingoutthetask,skinthathasbeenexpodmustbewashed,andifpossible,takingabathis
preferred.
(e)Takeprecautionssothatthedrugwouldnotcomeincontactwithskin,eyes,etc.
(f)Takeprecautionssothatsmokesfromsprayarenotinhaled.
(g)Beforeusing,takemeasuresnecessarysuchasputtingacover,preventthedrugfromcomingin
contactwiththetableware,food,etc.
(h)Placealidoverthewatertankbeforeorduringtheutokeepthechemicalsolutionfromentering.
tmaynotbeudinasituationwhereitmaycomeincontactwiththefollowinganimalsorplants(state
allrelevantitems):
(a)Animals
(b)Fish
(c)Avian(birds)
(d)Agriculturalproducts
(e)Otheritems
eandcollectionofcontainers,etc.
(a)Itshallnotbemovedtoandstoredinothercontainersthatcanbemisunderstoodasfood,lbestored
inasafeplaceinitsoriginalcontainerinconformitywiththestatedmethodofstorage.
(b)Tightlyclothecontainerwithalidandkeepoutofthereachofchildren.
(c)nsshallbealsotakenwhenreusingor
discardingthecontainerthroughapropermethod,becauthechemicalmaycomeincontact.
Article40(PackagingUnit)
Mattersconcerningthecontainerandunitofpackagingshallbewrittenaccordingtothefollowing:
ingcontainersshallhavedescriptionssothatmaterialsandthelevelofconfidentialitycanbeknown.
ordosageunitofapertinentproductshallbeindicatedproperlyforitspurpo.
Article41(StorageMethodandPeriodofU(ValidPeriod))
TheprovisionsofArticle16shallapplymutatismutandistothestoragemethodandperiodofu(validperiod).
Article42(StandardsandTestMethods,etc.)
TheprovisionsofArticles17and18shallapplymutatismutandistothemethodforwritingitemssuchasthe
s,rash,,ekmedicaladvice.
40
standards,testmethods,manufacturer,etc.
Article43(Conditions,ission)
(1)NotwithstandingtheprovisionsofArticle34(1),ifanemergencysuchastheoutbreakofunexpectedinfectious
diaoccurs,butsupplyinginfectiousdia-preventivedisinfectantsandincticides,icult,the
MinisterofMFDSmaygrantpermissionwithoutaparatesafetyandeffectiveevaluationorareviewofstandards
andtestmethods,ifthereisarequestmadebytheMinisterofMinistryofNationalDefen,DirectoroftheCenters
forDiaControlandPrevention,cas,
followingconditionsofpermissionshallapply:
andefficacydataandthestandardsandtestmethodspursuanttotheprovisionsofArticles44through47
shallbesubmittedwithinoneyearfromthepermissiondate.
ecordofproducing,importing,andllingpertinentproductsandabnormalresponsthatareconsidered
tohaveoccurredasaresultofusingpertinentproductsshallbereportedmi-annuallybythe20thofthemonth
followingtheendofeachhalf-year.
tpackagingandcontainershallindicatethat“Thisisaproductforurgentdiacontrolandhasnotgone
throughtheevaluationofsafety,efficacy,andstandardsandtestmethodsbytheMinisterofMFDS.”
(2)ProvisionsinArticles36through42maynotapplytotheproductstobeexportedandtheproductsthatare
intendedtobesuppliedtoorrervedformilitaryorgovernment,ifthereisaclearregulationsuchasthepurcha
noticeorspecification,etc.;however,ifoneintendstodomesticallylltheproductsthathavebeenpermittedas
productsforimport,formilitaryorforgovernment,conditionsforimport,formilitary,orforgovernmentmaybe
releadforproductsthatarenotrestrictedbyArticle11oftheRulesontheSafetyofDrugs,na
reevaluationofsafety,efficacy,cas,itshallcomplywiththeprovisionsof
Articles36through42.
(3)Ifanapplicationissubmittedforpermissionforaproductofmanufacture(orimport)badonatransferpursuant
toArticle8oftheRulesontheSafetyofDrugs,etc.,permissionmaybegrantedundertheconditionthatallmatters
permittedtothetransferorshallbesucceeded.
Article44(SubjectsofSafetyandEfficacyevaluationandPreparationofEvaluationData)
(1)Infectiousdia-preventivedisinfectantsandincticidesthataresubjecttothesafetyandefficacyevaluation
shallbetheinfectiousdia-preventivedisinfectantsandincticidesforwhichpermissionorpermissionfor
revisionsisrequired;however,changesintheproductname,changesinthepackagingunit,andtransfer(including
changeofmanufacturerduetotransfer)shallbeexcluded.
(2)Dataneededfortheevaluationofsafetyandefficacyofinfectiousdia-preventivedisinfectantsand
incticidesshallbepreparedfollowingAnnexFormNo.2,andthedatadefinedbytheprovisionsofArticles44
through47shallbesubmitted.
(3)SubmitteddatashallcomplywiththerequirementspursuanttoArticle47,andforeachitem,listofdata,index
numberandpageforeachdatashallbeindicatedintheordershowninArticle45;however,iftherequireddataare
remittedoromittedaccordingtotheprovisionsofeachArticle,thereasonsshallbestatedindetail.
(4)Ingeneral,regardingdatafromoveras,asummarywritteninKorean(anexcerptofthemainterms)andthe
41
ywhennecessary,completetranslationoftheentiredocument(signed
byaconfirmerwhohasanexpertknowledgeinmedicineandpharmacy)mayberequestedtobesubmitted.
Article45(TypesofDataforSafetyandEfficacyevaluation)
Datatobesubmittedforthesafetyandefficacyevaluationofinfectiousdia-preventivedisinfectantsand
incticidesshallbeasfollows:
ordiscoveryandthedevelopment
outstructuraldeterminationandphysicochemicalcharacteristics
(a)Structuraldetermination
(b)Physicochemicalcharacteristics,etc.
(c)Dataaboutstandardsandtestmethods
data
Long-termstoragetestdata,oracceleratedtestdata
tytestdata
(a)Singledotoxicitytestdata
1)Ingeneral,forsingledotoxicitytestdata,testdatashallbesubmittedforallexpodroutesofadministration
(oral,transdermal,inhalation,etc.).
2)Ifsingledooralandtransdermaltoxicitytestsarenotpossible,andthemajorrouteofexposureisinhalation,
onlythesingle-doinhalationtoxicitytestdatashallbesubmitted.
3)Forproductswhomainingredient’ssteampressureisnogreaterthan10-3mmHg(20℃)orforwhichthereis
noconcernforexposurethrougharespiratorysystem,inhalationtoxicitytestdatamaybeomitted.
(b)Repeateddotoxicitytestdata
1)Ingeneral,forrepeatedadministrationtoxicitytestdata,testdatashallbesubmittedforallexpodroutesof
administration(oral,transdermal,inhalation,etc.).
2)Ifrepeatedoralandtransdermaltoxicitytestsarenotpossible,andthemajorrouteofexposureisinhalation,
onlytherepeatedinhalationtoxicitytestdatashallbesubmitted.
3)Forproductswhomainingredient’ssteampressureisnogreaterthan10-3mmHg(20℃)orforwhichthereis
noconcernforexposurethrougharespiratorysystem,inhalationtoxicitytestdatamaybeomitted.
(c)Reproductiveanddevelopmentaltoxicitytestdata
(d)Genotoxicitystudydata
(e)Carcinogenicitytestdata
(f)Othertoxicitytestdata(localtoxicity,nervoustoxicity,antigenicity)
1)Localtoxicitytestdatashallbesubmittedifinfectiousdia-preventivedisinfectantsandincticidescan
easilycomeincontact,eveniftheyarenotdirectlyappliedtoordonotdirectlyapplytotheskinorthemucous
membrane.
2)Nervoustoxicitytestdatashallbesubmittedforinfectiousdia-preventivedisinfectantsandincticides
whichinhibitorarelikelytoinhibitvitalizationofacetylcholinestera
3)Antigenicitytestdatashallbesubmittedforincticidesthatpreventinfectiousdiastowhichtheentire
bodyixpod,andskinnsitizationtestdatashallbesubmittedwhentheskinislikelytobeexpod.
42
(g)Environmentalhazardtestdata
1)Ecologytoxicitytestdatasuchasthefishtoxicitytest,etc.
2)Residuetestdata
Iftheresidueisnotlikelytoporiskdependingonthemethodofu,formulation(e.g.,repellent,etc.)orthe
resultofatoxicitytest,thedatashallberemitted.
3)Bioconcentrationtestdata
Thistestshallberemittedwhenoctanol-waterpartitioncoefficientislow(logPow≤3).
cydata
tion,distribution,metabolism,andexcretiondata
asusagestatusdata
ativereviewwithsimilardomesticproductsandcharacteristicsofapertinentquasi-drug
Article46(ScopeofSubmission,forSafetyandEfficacyevaluation)
(1)Scopeofsubmissionofdataforthesafetyandefficacyevaluationofinfectiousdia-preventivedisinfectants
andincticidesshallbeasshowninAppendix8.
(2)FormattersthatarenotdefinedbyAppendix8,ator,Inhibitor,RepellentandInct-AttractingPesticides
forFlies,Mosquitoes,rPeopleandAnimals’fQuasi-DrugsandRequired
Datashallapply.
Article47(RequirementsofDataforSafetyandEfficacyevaluation)
Requirementsofdatatobesubmittedforthesafetyandefficacyevaluationofinfectiousdia-preventive
disinfectantsandincticidesshallbeasfollows:
ordiscoveryandthedevelopment
DatathatareclearlywrittenaccordingtothefiveWsandoneH(5W1H)principleaidinginmakingajudgment
concerningthesafetyandefficacyofpertinentinfectiousdia-preventivedisinfectantsandincticides(e.g.:
who,when,where,whatwithregardstotheextraction,parationorsynthesis;whatwastheoriginofdiscovery;
whenandwheredidtheprimarytesting,,etc.)
outstructuraldeterminationandphysicochemicalcharacteristics
(a)Structuraldetermination
Origin,intrinsiccharacteristics,composition,inalrawmaterialsspecificationsthatcanaidinmakinga
judgmentconcerningthebasicrequirementsasinfectiousdia-preventivedisinfectantsandincticides.
(b)Physicochemicalcharacteristics,etc.
1)Manufacturingmethodofinfectiousdia-preventivedisinfectantsandincticides
2)Physicochemicalorbiologicalcharacteristicssuchasthemeltingpoint,boilingpoint,steampressure,solubility
andoctanol-waterpartitioncoefficient
3)Asforoctanol-waterpartitioncoefficient,actualmeasurementordatabadonacalculationshallbesubmitted;
however,thismaybeomittedforchemicalsubstanceswithwatersolubilitynolessthan100mg/Landhigh
polymers.
(c)Dataaboutstandardsandtestmethods
43
StandardsandtestmethodswhicharepreparedpursuanttotheregulationsofArticle42,ornotificationofthe
resultofevaluationofstandardsandtestmethods(includingthetestdatapreparedbythepertinentbusiness)
data
Datashallcorrespondtooneofthefollowing:
(a)GeneralInformation
1)AsdatathatareincompliancewiththeStandardsforDrugStabilityTest(MFDSNotice)announcedbythe
MinisterofMFDS,primarytestdataofwhichthetestiscarriedoutdomesticallyshallbeattached.
2)Notwithstandingtheprovisionsof1),regardingdataforwhichtestiscarriedoutabroad,itmaybeapprovedif
itisconsidered,badonareviewofdetails,thatthesafetycanbecured.
(b)Testmethods,etc.
1)Long-termstoragedataoracceleratedtestdatawhichcorrespondtooneofthefollowingshallbesubmitted;
however,whensubmittingtheacceleratedtestdata,measurementintervalshallbenogreaterthanoneweek:
a)Ifperiodofu(validperiod)isoneyear,datathataretestedforatleasttwoweeksat54±2℃
b)Ifperiodofu(validperiod)istwoyears,datathataretestedforatleastfourweeksat54±2℃
c)Ifperiodofu(validperiod)isthreeyears,datathataretestedforatleastsixweeksat54±2℃
d)Ifitisnotpossibletocarryoutatestatapreviouslymentionedtemperatureduetothecharacteristicsofa
mainingredient,datathataretestedatothertemperaturesandperiods(dataofwhichthetestiscarriedoutat
45±2℃forsixweeks,at40±2℃foreightweeks,at35±2℃for12weeks,at30±2℃for18weeksshalleach
beconsideredtohaveaperiodofu(validperiod)ofoneyear)shallbeadmitted.
tytestdata
(a)Generalinformation
Datashallcorrespondtooneofthefollowing:
1)DataofwhichthetestiscarriedoutaccordingtotheGoodLaboratoryPractices(GLP)
2)Astoxicitytestdatathataresubmittedandevaluatedatthetimeofapplyingforpermissioninthecountry
wherethepertinentquasi-drugisdevelopedwhich,dataareverifiedtobesubmittedtoorapprovedbythe
government(permissionorregistrationorganization)ofthecountrywheredevelopmenttookplace;ordatathat
notarizethis.
(b)TestMethod,etc.
1)ForArticle45(4)(a)through(f),dataofwhichthetestsareconductedproperlypursuanttotheStandardsfor
DrugToxicityTest,RegulationsontheDesignation,archInstitutesforChemicalHazardTest
(NationalInstituteofEnvironmentalRearchNotice),andRegistrationStandardsofAgriculturalPesticides
(RuralDevelopmentAdministrationNotice)andofwhichthetestmethods,sideredtobevalid
scientificallyandrationally.
2)ForArticle45(4)(g),dataofwhichthetestsareconductedproperlyinaccordancewiththemethodsfor
chemicalhazardtestspursuanttotheRegulationsontheDesignation,archInstitutesforChemical
HazardTest(MinistryofEnvironmentNotice),ordataofwhichthetestmethods,sideredtobe
validscientificallyandrationally.
cydata
44
(a)Generalinformation
1)Dataofwhichthetestisconductedataprofessionalorganizationathomeorabroadsuchasauniversityora
rearchinstituteandwhichareissuedbytheheadoftheorganizationandcanbeconsideredasvalidbadon
thereviewofitscontent(inthisca,summaryofthetestfacilitiesintherearchorganization,compositionof
thehumanresourceforrearch,rearchexperiencesofthetestingpersonnel,edescribed.).
2)Asdatathataresubmittedandevaluatedatthetimeofapplyingforpermissioninthecountrywherethe
pertinentquasi-drugisdeveloped,dataareverifiedtobesubmittedtoorapprovedbythegovernment
(permissionorregistrationorganization)ofthecountrywheredevelopmenttookplace;ordatathatnotarize
this.
3)DatapublishedinanacademicjournalregisteredintheScienceCitationIndex.
(b)Testmethod
Asdataofwhichtheefficacytestisconductedoutsideorinalaboratoryregardingthespecies,ful
inctslivingthenation,summaryofthetestresultshallbepreparedaccordingtotheexampleofpreparationin
AnnexFormNo.3;however,forincticides,testdata(includingnsitivitytestdata)ofwhichthetestis
conducteddomesticallywithinfiveyearsfromthedateofapplicationforpermissionshallbeattached:
1)Forinfectious-diapreventivedisinfectantsandincticidescontainingnewmaterials,datashallcomefrom
teststhatareconductedusingeachharmfulinctunderconsideration.
2)Forproductsofwhichtheeffectiveincticidalingredientshowstheeffectthroughtranspiration,datathat
showtherelationshipbetweenthetimeandtheamountoftranspirationshallbeadditionallysubmitted.
tion,distribution,metabolism,andexcretiondata
(a)Generalinformationisthesameasthesubparagraph5(a).
asusagestatusdata
ativereviewwithsimilardomesticproductsandcharacteristicsofapertinentquasi-drug
Comparisonwithasimilardomesticproductshallbeprentedinacomparativetable,anddataaboutthe
packagingandlabelingofapertinentproductshallbeattached.
Article48(RemissionofDataRequiredforSafetyandEfficacyevaluation)
Ifoneofthefollowingisapplicable,toxicitytestdatadefinedinArticle45,subparagraph4anddataconcerningthe
absorption,distribution,metabolism,andexcretiondefinedinArticle45,subparagraph6shallberemitted;however,
inthecaofsubparagraph3,partofthedatamayberemitted:
roduct(productforwhichingredient,content,andformulationareindicated)isacknowledgedbythe
WHOPesticideEvaluationScheme(WHOPES);however,datawhichprovethateachsubparagraphofArticle35
(2)isnotapplicableshallbesubmitted.
thatcanobjectivelyprovethattheproductisudbyatleasttwocountriesintheOECDcountriesis
attached(excludingthetestdataontheenvironmentalhazard);however,datawhichprovethateachsubparagraph
ofArticle35(2)isnotapplicableshallbesubmitted.
aresubmittedconcerningtheusagestatusthroughwhichtheproductcanbeofficiallyapprovedasa
productthatwouldbeconsidered,badonacomprehensivejudgmentmadeatamodernscientificlevel,as
havinganequivalentorhigherqualificationthantheproductthathasalreadyreceivedpermission.
45
Article49(Preparation,estforEvaluationofStandardsandTestMethods)
TheprovisionsofArticles26through32shallapplymutatismutandistothepreparationofarequestforevaluationof
standardsandtestmethodsforinfectiousdia-preventivedisinfectantsandincticides,establishmentofstandards,
scopeofrequireddata,etc.
Chapter6SupplementaryRules
Article50(RevisionofItemsofPermissionandNotification)
(1)NotwithstandingtheprovisionsofArticles8through20and36through43,theMinisterofMFDSmayre-
establish(unifyandadjust)thecategoriesforpermissionornotificationbyproductthroughtheManufacturing
StandardsforDrugs,etc.,evaluationofsafetyandefficacy,otherevaluationsofsafetyinformation,evaluationof
standardsandtestmethods,listanddeletionoftheSpecificationStandardsofMFDS,etc.
(2)IftheMinisterofMFDSre-establishes(unifiedandadjusted)mattersrelatedtothepermissionforor
notificationofproductsinparagraph(1)pursuanttotheprovisotoArticle8(1)oftheRulesontheSafetyofDrugs,
erschangingcategoriesforpermissionforornotificationofthepertinentproductbyacertaindeadline
pursuanttoArticle76(1)ofthePharmaceuticalAffairsAct,parateproceduresforpermissionforornotificationof
changesshallbeomitted,anditshallbeconsideredasifthepermissionforornotificationofchangeshasbeen
procesdbytheMinister
cas,themanufacturerorimporterofthepertinentproductshallwrite“[deadlineforinstructingchanges][categories
permittedforchanges]change(documentnumberanddate)”onthereversideofthecertificateofpermissionfor
product(ornotificationcertificate)andattachthedetailsofthechanges.
Article51(ProductsContainingProblematicIngredientsforSafetyandEfficacy)
ProductsthatcontainingredientsthatareproblematicforsafetyandefficacypursuanttoArticle11(1)8oftheRules
ontheSafetyofDrugs,easfollows:
tsthatcontainingredientsthatareproblematicforsafetyandefficacypursuanttoArticle54ofthe
RegulationsonthePermission,Notification,andEvaluationofQuasi-Drugs;however,externalapplications
containingacetanilide,incticidescontainingboricacidanditssalt(but,incaoftheboricacid,itmaybe
mixedonlyforbathsproducts),andhairdyeproductscontainingphenacetinshallbeexcluded;
onthatcontainschlorpyrifos;
lproductsthatcontainmorethan0.25%allethrin;
lrepellentsthatcontainmorethan0.5%permethrin.
Article52(SupplementationofData)
(1)Ifoneofthefollowingreasonsisapplicabletothepermissionforornotificationofproductortherequestfor
evaluations,theMinisterofMFDSshallspecifythenecessarymattersindetailandrequestsupplementationfroma
personwhosubmittedthedata.
,scopeorrequirement,atathathavebeenattachedtotheapplicationarenotincompliancewith
theprovisionsofeachArticle;
46
thereviewofasubmitteddata,ithasbeenconsideredthatadditionaldata,ticularlynecessary
forresolvingasignificantissuethatmayhappentothesafety,efficacyandqualityofaproduct.
(2)Withregardstotheperiodforsupplementingdatapursuanttoparagraph(1),sufficienttimeshallbegrantedfor
thecivilpetitionertopreparethesupplementationdata,
timeatwhichsubmissionismadebythecivilpetitionershallbeconsideredastheendpointofthesupplementation
requestperiod,eorpartofthedatathathavebeenrequestedtobesupplemented
isnotsubmittedwithinthisperiod,supplementationmayberequestedagainwithin10daysasasupplementation
r,ifthecivilpetitionerrequestxtensionofperiodbyspecifyinganecessaryperiodforthe
reasonthathe/sheisnotabletopreparesupplementationwithintherequestedsupplementationperiod,
cas,thenumberofrequeststhatcan
bemadebyacivilpetitionerregardingtheextensionofperiodshallbelimitedtotwo.
(3)Ifitisdeterminedthatoneofthefollowingisapplicableduringareviewof,orbadontheresultofareviewof,
theapplicationforpermissionforornotificationonproductortherequestforevaluations,theMinisterofMFDSmay
specifythereasonsindetailandreturntheapplicationtothepersonwhosubmittedthedata:
ataarenotsubmittedwithinaperiodduringwhichsupplementationhasbeenrequestedtobesubmitted
pursuanttoparagraph(2);
afetyandefficacyasaquasi-drugoritsstandardsandtestmethodsarenotadequateduetothe
noncompliancewiththeevaluationstandardspursuanttoArticles7,9,11,12,13,16,17,22,36,37,38,41,42,44
andChapter4.
Article53(ProcessingofReapplicationDocuments)
Regardingaproductforwhichapplicationforpermissionoftheproduct(includingpermissionforchanges;thesame
shallapplyinthisArticle.),notificationoftheproduct(includingnotificationofchanges;thesameshallapplyin
thisArticle.),orarequestforevaluationhasbeenreturnedpursuanttoArticle52(3),reapplicationsthathavebeen
submittedforpermissionforornotificationontheproductorforarequestforevaluationwithinaperiodthathasnot
pasdtwoyearsfromthereturndatebysupplementingthemattersspecifiedineachsubparagraphofArticle52(3)
r,ifanadditionalreviewofdataisnecessary,
suchasthecaofadditionallydiscoveringamatterthatsignificantlyaffectsthesafetyandefficacyofarelevant
quasi-drug,etc.,correspondingreviewsshallbeexecuted.
Article54(Consultation,etc.)
Ifitisdeemednecessaryforpermissionforornotificationofquasi-drugsandtheevaluationofsafety,efficacy,
andstandardsandtestmethodsofquasi-drugspursuanttothisnotice,theMinsterofMFDSmaylistentotheopinion
oftheDirectorGeneraloftheNationalInstituteofFoodandDrugSafetyEvaluationorconsulttheNational
PharmacistsCommittee.
Article55(ProvisionsAppliedMutatisMutandis)
FormattersthatarenotdefinedbythisNoticeconcerningthepermissionornotificationofmanufacture(import)for
quasi-drugs,RegulationsonthePermission,Notification,andEvaluationofDrugs;StandardsforDrugStabilityTest;
47
orStandardsforDrugToxicityTestshallapply.
Article56(ReexaminationDeadline)
ThisNoticeshallbeexaminedforitsappropriatenesverythreeyearsasofJanuary1,2014(byDecember31
everythirdyear)pursuanttoArticle8oftheFrameworkActonAdministrativeRegulationsandtheRegulationson
theIssuanceandManagementofInstructions,EstablishedRules,etc.(PresidentialInstructionsNo.248),andproper
measuresforimprovement,etaken.
Article1(EnforcementDate)
SupplementaryProvision<09/15/2010>
ThisNoticeshallbeeffectivefromthedateofitsannouncement.
Article2(RevocationofOtherDecrees)
RegulationsonthePermissionfor(orNotificationof)Disinfectants,Incticides,ventionofInfectious
DiasannouncedbytheMinisterofMFDSalongwiththeenforcementofthisNoticeshallbeabolished.
Article3(InterimMeasures)
(1)ApplicationsthathavebeensubmittedalreadytotheMinisterofMFDSortheCommissionerofRegionalOffice
ofMFDSatthetimeofthisNoticeforthepermissionfor(ornotificationof)quasi-drugs,evaluationofsafetyand
efficacy,andevaluaeappliesto
theapplicationforregisteringchanges.
(2)Quasi-drugsthathavereceivedtheevaluationofsafetyandefficacyorevaluationofstandardsandtestmethods
pursuanttothepreviousRegulationsonthePermission,Notification,andEvaluationofDrugs,
RegulationsonthePermissionfor(orNotificationof)Disinfectants,Incticides,ventionofInfectious
DiasshallbeconsideredashavingreceivedevaluationspursuanttothisNotice.
Article4(AmendmentofOtherNotices)
PartoftheRegulationsonthePermission,Notification,andEvaluationofQuasi-Drugs,announcedbythe
MinisteroftheFoodandDrugAdministrationalongwiththeenforcementofthisNoticeshallbeamendedasfollows:
Thetitle“RegulationsonthePermission,Notification,andEvaluationofDrugs,etc.”shallberevidas
“RegulationsonthePermission,Notification,andEvaluationofDrugs.”InArticle1,“permissionfor,ornotification
ondrugsandquasi-drugsbyamanufactureroranimporterofquasi-drugs,andsafetyandefficacyofdrugsand
quasi-drugs”shallberevidas“permissionfor,ornotificationondrugimports,andsafetyandefficacyofdrugs.”
InArticles5(1),6(1),7,10(8),14(2),21(2),25(2),31(1),57(1),and60,“drugs,etc.”shallberevidas
“drugs,”andinArticle60,“StandardsforBiologicalEquivalenceTest,andtheRegulationsonthePermissionfor
(orNotificationof)Disinfectants,Incticides,ventionofInfectiousDias”shallberevidas
“StandardsforBiologicalEquivalenceTest.”InChapter3(Articles41through51),Appendices16and17shall
eachbedeleted,andinAppendix18,subparagraphs1,30,itleofAnnex
48
Form1,“Article26andArticle44”shallberevidas“Article26,”andquasi-drugsctionIandctionsIII
throughVIshalleachbedeleted.
tsthatcontainacetanilide
tsthatcontainboricacidanditssalt(excludingophthalmicproductsandepidermalformulationswitha
mixinglimitnogreaterthan1.8%)
tsthatcontainphenacetin
Article5(RelationshipwithOtherNotices)
WhenthepreviousRegulationsonthePermission,Notification,andEvaluationofQuasi-Drugs,etc.;theRegulations
onthePermissionfor(orNotificationof)Disinfectants,Incticides,ventionofInfectiousDias;or
theirprovisionsarequotedinotherregulationsatthetimeofthisNotice,correspondingregulationsinthisNotice,if
therearecorrespondingregulationsinthisNotice,shallbeconsideredashavingbeenquotedinlieuoftheprevious
regulations.
Article1(EnforcementDate)
SupplementaryProvision<02/01/2011>
ThisNoticeshallbeeffectivefromthedateofitsannouncement.
Article2(InterimMeasuresConcerningtheApplicationforPermission,etc.)
Applicationsforpermissionfor(ornotificationof)ofquasi-drugsthathavebeenregisteredalreadyaccordingtothe
previousregulationsatthetimeoftheenforcementofthisNoticeshallcomplywithpreviousregulations.
SupplementaryProvision
Article1(EnforcementDate)
(1)ThisNoticeshallbeeffectiveonemonthafterthedateofitsannouncement.
(2)Omitted.
Article2throughArticle3
Omitted.
Article4(AmendmentofOtherNotices)
(1)-(3)Omitted.
(4)IntheRegulationsonthePermission,Notification,andEvaluationofQuasi-Drugs(MFDSNoticeNo.2011-5),
“copoeia”shallberevidas“KoreanPharmacopoeia.”
(5)-(12)Omitted
Article5(RelationshipwithOtherRegulations)
Omitted.
49
SupplementaryProvision
(RegulationsontheSafetyStandards,etics)
Article1(EnforcementDate)
ThisNoticeshallbeeffectiveonemonthafterthedateofitsannouncement.
Article2throughArticle4
Omitted.
Article5(AmendmentofOtherDecrees)
(1)Omitted.
(2)RegulationsonthePermission,Notification,andEvaluationofQuasi-Drugs(MFDSNoticeNo.2011-5,2/1/2011)
shallbeamendedasfollows:
InArticle9(3)2(i),“standardsforrawmaterialsofcosmeticsspecifiedbyAppendix1intheRegulationsonthe
DesignationofRawMaterialsforCosmetics“shallberevidas“Part4AdditivesineachArticleofquasi-drugsin
theStandardsandTestMethodsforQuasi-Drugs(MinistryofFoodandDrugandSafetyNotice).”
(3)-(4)Omitted.
SupplementaryProvision
Article1(EnforcementDate)
ThisNoticeshallbeeffectivefromthedateofitsannouncement;however,amendedregulationsinAppendix1
(applicableonlytothepartconcerningwettissuefororalhygiene)shallbeeffectiveonemonthafterthedateofits
announcement.
Article2(Application)
ThisNoticeshallbeapplicablebeginningwiththefirstapplicationforpermissionforornotificationofquasi-drugs
thatissubmittedtotheMinisterofMFDSortheCommissionerofRegionalOfficeofMFDSaftertheenforcementof
thisNotice.
Article3(InterimMeasures)
(1)Itemsthatarepermittedandnotifiedasquasi-drugsaccordingtothepreviouslawsandregulationsatthetimeof
theenforcementofthisNoticeshallbeconsideredaspermittedornotifiedpursuanttothisNotice.
(2)ApplicationsthathavebeensubmittedalreadytotheMinisterofMFDSandtheCommissionerofRegionalOffice
ofMFDSforpermissionforornotificationofproductsasquasi-drugs(includingapplicationforchanges)atthetime
ofthisNoticeshallcomplywiththepreviousregulations.
SupplementaryProvision
50
Article1(EnforcementDate)
ThisNoticeshallbeeffectivefromthedateofitsannouncement.
SupplementaryProvision
ThisNoticeshallbeeffectivefromthedateofitsannouncement.
SupplementaryProvision
Article1(EnforcementDate)
ThisNoticeshallbeeffectivefromthedateofitsannouncement.
Article2(InterimMeasuresaboutMasks)
Productsthatarepermittedasyellowdustpreventivemasksordiapreventionmasksaccordingtotheprevious
regulationsatthetimeoftheenforcementofthisNoticeshallbeconsideredaspublichealthmasksthatarepermitted
pursuanttotheregulationsofthisNotice.
SupplementaryProvision
ThisNoticeshallbeeffectivefromthedateofitsannouncement.
SupplementaryProvision
ThisNoticeshallbeeffectivefromthedateofitsannouncement.
SupplementaryProvision
Article1(EnforcementDate)
ThisNoticeshallbeeffectivefromthedateofitsannouncement.
Article2(InterimMeasures)
PreviousmanufacturerandimporterofaproductthatfallsundertheV-2inAppendix3ofArticle24(1)shallreport
thequasi-drugsmanufacturebusinesspursuanttothePharmaceuticalAffairsActandtheRulesontheSafetyof
Drugs,etc.(OrdinanceofthePrimeMinister)beforeOctober1,2016andreceivepermissionforthepertinent
cas,he/shemaysubmitthereportofa
manufacturerandapplyforpermissionfortheproductbeforeOctober1,strationasamanufacturerand
approvalofpermissionfortheproducthavebeencompletedbeforeOctober1,2016,October1,2016shallbe
consideredasthedateofregistrationasamanufacturerandthedateofpermissionfortheproduct.
51
[Appendix1]
PrervativesforQuasi-DrugsandtheRangeofUsage
(InRegardstoArticle9,(5)3)
NameofIngredient
SolidandLiquidPreparation
forInternalUandWet
TissueforOralHygiene
Preparationsfor
ExternalU
Toothpastes
Note
Permissible
Range(%)
Daily
Permissible
Do
PermissibleRange
(%)
Permissible
Range
(%)
Benzoicacid
≤0.06≤5mg/kg
0.5(asanacid);
however,for
productsthatare
washedafterbeing
ud,2.5(asan
acid)
≤0.3
Sodiumbenzoate
≤0.06≤5mg/kg
Methylperoxybenzoate
≤0.01≤10mg/kg
Asasingle
ingredient,no
greaterthan0.4(as
anacid)
Ifudbymixing,
Nogreaterthan0.8
(asanacid)
≤0.2
Ethylperoxybenzoate
≤0.01≤10mg/kg
Propylperoxybenzoate
≤0.01≤10mg/kg≤0.2
Butylperoxybenzoate
≤0.01≤10mg/kg
Sorbicacid
≤0.2
≤25mg/kg
≤0.6(asanacid)
Potassiumsorbate
≤0.2
≤25mg/kg
Sodiumsorbate
≤0.2
≤25mg/kg
Chlorobutanol
≤0.5
Nottobeud
onaerosol
products
Benzalconiumchloride
≤0.05(For
productsthatare
washedafterbeing
ud,≤0.1)
Benzethoniumchloride
≤0.1
Phenol
≤0.1
Chlorocresol
≤0.2
Benzylalcohol
≤1.0(Forhairdye
products,≤10asa
solvent)
Phenoxyethanol
≤1.0
Methylchloroisothiazolinoneand
methylisothiazolinonemixed
solution(includingmagnesium
chlorideandmagnesiumnitrate)
≤0.0015
(methylchloroisothi
azolinone:
methylisothiazolino
ne=(3:1)asa
52
mixture)
ImidazolidinylUrea
≤0.6
※NOTE
concentrationisW/V%forliquidpreparations,andW/W%forotherpreparations.
xingmorethantwotypesofprervativesofthesamekind(group),thetotalamountshallnotexceed
themaximumforeachingredient.
xingprervativesofdifferentkinds(groups),thereshallbeabasisandthetotalamountshallnot
exceedthemaximumforeachingredient.
iquidpreparationsforinternalu,for"itemsthatareudrepetitivelyafteropeningbydividingfor
administration,"permissiblerangesforbenzoidacidsandperoxybenzoicacidsshallbenogreaterthan0.1%.
ofthewettissuesfororalhygiene,ifoneintendstoexceedthevalidconcentrationformanufacturing
pharmaceuticalreasons,itmaybeallowedwithintherangeofthedailypermissibledo(but,amongliquids
forinternalu,alterativeforenergyenhancement,stomach-strengtheningdigestivemedicines,andother
medicationsforthecirculatorysystemshallbeexcluded).However,insuchcas,clearreasons,
physicochemicalexplanations,andtheprervationpowertest(B.P.)datashallbesubmitted.
xingaprervativetosolidpreparationsforinternalusuchaspills,tablets,capsules,etc.,its
permissiblerangeshallcomplywiththestandardsforapermissiblerangeofaliquidpreparationandadaily
permissibledo.
ationsforexternalumeanpreparationsforexternaluamongquasi-drugsthatfallunder
subparagraph2oftheDesignationoftheScopeofQuasi-Drugs(MFDSNotice),andproductsthatarenot
directlyappliedtotheskinsuchasincticides,eexcluded.
gredient,despitebeingknownalready,thatisnotdesignatedisintendedtobeudasaprervative,or
ifaprervativeamongpreparationsforexternaluisudinexcessofitsusagerange,aclearbasisforu,
physicalandchemicalevidence(includingaprervationpowertestdata),andifnecessary,comparativetest
reasonsformixingandtheamountudshallbejudgedtobevalid.
thpastes,0.2%ofsodiummethoxideρ-oxybenzoate,whichisasaltofmethylρ-oxybenzoate,and0.1%of
sodiumpropylesterρ-oxybenzoate,whichisasaltofpropylρ-oxybenzoate,yshallbe
consideredasprervativesofthesametype(group).
53
[Appendix2]
GuidelinesforDescriptionofManufacturingMethods
(InRegardstoArticle11(2))
Followingformmaybeud,oramanufacturingdiagramorotherdescriptionmethodscontainingthefollowingform
maybeud.
sName
Rawmaterial,reagent,solvent,
1
Note
1Note2
Weighingofraw
materials
ManufactureroftheMain
IngredientNote3
ː
ː
ː
PackagingNote4
Materialofdirectcontainerand
packaging
Note1:Namesofrawmaterials,reagents,solvents,eaddedandudshallbestatedbyprocess.
Note2:ForProcessNo.1,「ProcessName」columnshallbefilledinwith"Weighingofrawmaterials";「Raw
material,reagent,solvent,etc.」shallbefilledinwiththenamesofrawmaterials,reagents,solvents,
areaddedandudduringtheentireprocess;andthe「Note」columnshallbefilledinwiththemanufacturer
ofthemainingredient.
Note3:「ManufactureroftheMainIngredient」shallbefilledinwiththenameandlocationofthemanufacturerof
manufacturedbyconsigningthewholeorpartoftheprocess,nameandlocationof
dmitteroftheitem(contract
manufacturer)andtheactualmanufacturer(consignedmanufacturer)aredifferent,thisshallbedistinguished
hepreparation'smainingredientisintheformofahalf-finishedproduct,namesandlocations
ofnotonlythemanufacturerofapertinentmainingredient,butalsothemanufacturerofthesubstancesthatare
expectedtomanifesttheefficacyandeffectdirectlyorindirectly(e.g.:effectenhancer,etc.)shallbestated
together.
Note4:Forthelastprocess,「ProcessName」columnshallbefilledinwith"Packaging,"andthe「Note」column
roneousconsumptionpreventive
containerisudforsolidformulationincticides,materialandastructuraldiagramoftheerroneous
consumption-preventivecontainershallbestated.
54
55
[Appendix3]
ScopeofSubmissionofDataforSafetyandEfficacyevaluation
(InRegardstoArticle24(1))
Ⅰ.Asafiber,rubberorpapersprovidedforsanitarypurpos,sanitarypads,cover,wrap,
gauze,absorbentcotton,band-aids,andothersimilarproducts
Datatobe
submitted
Category
1
123
4
567
ABCDEFG
Preparationcontainingnew
materialsNote2
○○○○○
△
○○×○
△
○○
NewMaterialsNote3○○○○
△△△△
×○
△
○○
NewUsageDirections○○×××××××
△△
○○
NewEfficacy○○××××××××
△
○○
○:Datathatmustbesubmitted
△:Datathatmayberemittedbadonthejudgmentforindividualitems,becauthesubmissionis
notmeaningfulorpossible
×:Dataofwhichthesubmissionisremitted
Note1:DataNo.1through7refertothedatainsubparagraph1through7ofArticle23,andamongthe
toxicitydata(4),thomarkedwith※shallbethesingledotoxicitytestdataorthe
cytotoxicitytestdata.
Note2:"Preparationcontainingnewmaterials"ctionshallapplytoproductsthatcontainnew
materialsthroughspreading,processing,r,rubber,orpaperproducts.
Note3:“NewMaterials”ctionshallapplyifthefiber,rubber,orpapersthatcompotheproduct
isanewmaterial.
56
Ⅱ.Odorinhibitorssuchasbadbreath(halitosis)orbodyodoreliminators;hairtonic,hair
dye,depilatory,etc.;productsudfororalhygiene,etc.;andproductsthatareapplied
directlytohumanbodies
Datatobe
submitted
Category
1
123
4Note3
567Note
ABCDEFG
Preparationcontainingnew
materials
○○○○○
△
○○
△
○○○○
Note2
Mixedproductofnew
composition
○○○
△△
××
△
×
△
○○○
Content-varyingmixedproduct○○○
△
×××
△
×○
△
○○
Singleproduct○○○
△
×××
△
×
△
○○○
Newefficacyandeffect○○×××××
△
×
△
○○○
Newusagedirectionsanddo○○××××××××○○○
Newformulation○○○×××××××○○○
○:Datathatmustbesubmitted
△:Datathatmayberemittedbadonthejudgmentforindividualitems,becauthesubmissionis
notmeaningfulorpossible
×:Dataofwhichthesubmissionisremitted
Note1:DataNo.1through7refertothedatainsubparagraph1through7ofArticle23.
Note2:ofthepreparationsthatcontainnewmaterialsandthehairdye,toxicitytestdata
forpertinentnewmaterialsandeachingredientshallbesubmitted.
ofthemixedproductforexternaluthatcontainnewmaterials(excludinghair
dyeproducts),singledotoxicitytestdata,1-monthrepeateddotoxicitytestdata,and
mucousmembranestimulationtestdatashallbeadditionallysubmittedpursuantto
compositemedications,
otherthanthemixedproductsforexternalu,thatcontainnewmaterials,singledo
toxicitytestdata,1-monthrepeateddotoxicitytestdata,andmucousmembrane
stimulationtestdataunderthetoxicitytestmethodbymedicationformixedproductsin
theStandardsforQuasi-Drugdatashallbesubmittedadditionally.
57
matologicpreparationismadeasanaerosolproduct,efficacytestdataforthe
aerosolshallbeattached.
Note3:Remissionoftoxicitytestdata
activeingredientcontainsacrudedrugoracrudedrugextractthathave
precedentsofbeingudasdrugsorifeachingredientislistedintheStandardsand
SpecificationsofFoodAdditives(applicableonlytothefoodadditives),toxicitytestdata
mayberemittedinpartorwholeforproductsthatarelistedintheKorean
Pharmacopoeiaorintheofficialcompendiumasasingleproduct.
activeingredientislistedintheKoreanPharmacopoeia,StandardsandTest
MethodsforQuasi-Drugs,etc.,orifitisudforthesamepurpoasaningredientthat
ispermittedalready,toxicitytestdataformixedproductsmayberemitted.
58
Ⅲ.Extirpators,inhibitors,repellentsandinct-attractingpesticidesforflies,mosquitoes,etc.
thatareudtoprotectthehealthofpeopleandanimals
Datatobe
1
submitted
Category
123
45
67
ABCDEFGANote2BC
Preparationcontaining
newmaterials
○○○○○○○
△
○○○○○○○
Mixedproductofnew
compositionNote3
○○○
△△
××
△△△
○××○○
Content-varyingmixed
productNote3
○○○
△△
×××
△△△
××○○
Singleproduct○○○
△△
×××
△△△
××○○
Newefficacyandeffect○○××××××××○××○○
Newusagedirectionsand
do
○○××××××××○××○○
NewformulationNote3○○○
△△
×××
△△
○××○○
○:Datathatmustbesubmitted
△:Datathatmayberemittedbadonthejudgmentforindividualitems,becauthesubmissionis
notmeaningfulorpossible
×:Dataofwhichthesubmissionisremitted
Note1:DataNo.1through7refertothedatainsubparagraph1through7ofArticle23,while
clau(f)amongthetoxicitydata(4)datathatcan
verifytheefficacyandeffectshallbeasfollows:
atcanverifytheefficacyandeffect
icidalpowertestdata
lpharmacologicaltestdata(maybesubstitutedbythesafetypharmacologicaltest)
tion,distribution,metabolism,andexcretiontestdata
59
Note2:Forrepellents,incticidalpowertestdatashallbesubmittedthroughrepellantpowertest
data.
Note3:Iftheactiveingredienthasahighconcentration,adifferentcomposition,oranew
formulation,toxicitytestdatashallmeanthetoxicitytestdataofafinishedproduct.
※Ifitfallswithintherangeofthemainingredientcontentoftheitemthatispermitted(notified)
already,parateevaluationdatamaynotneedtobesubmitted.
※Comprehensivelyjudgingatthelevelofmodernmedicineandpharmacy,ifitisconsideredtobe
similarorequivalenttoaproductthatispermittedalready,datatobesubmittedmaybereplaced
witheusagestatusdatawhichcanbeapprovedpublicly.
60
Ⅳ.Contactlenscareproducts(cleaning,prerving,sterilizing,rinsingsolutions,s)
Datatobe
submitted
Category
1
123
45
67
ABCDE
ANote2B
tofwhichtheresidue
solutiondoesnotdirectlycontact
theeyes
Preparationcontainingnewmaterials○○○○○○○○○△○○
Otherpreparations○○○×○×××○△○○
tofwhichtheresiduesolutiondoesnot
directlycontacttheeyes
Preparationcontainingnewmaterials○○○○○×××○△○○
Otherpreparations○○○×○×××○△○○
○:Datathatmustbesubmitted
△:Datathatmayberemittedbadonthejudgmentforindividualitems,becauthesubmissionis
notmeaningfulorpossible
×:Dataofwhichthesubmissionisremitted
Note1:DataNo.1through7refertothedatainsubparagraph1through7ofArticle23,andthe
toxicitydata(4)andthedataconcerningthepharmacologicalactionshallbeasfollows:
ncerningthetoxicity
dotoxicitytestdata
irritationtestdata
xicitytestdata
nsitizationtestdata
EOcularmembrane’sbiologicalsynthesistestdata
outpharmacologicalactions
cytestdata
lpharmacologicaltestdata
Note2:Afficacytestdataforsterilizinganddisinfectionpower,cleaningpower,protein
61
removingpower,esubmitted;however,theefficacytestdatashallberemittedfor
ntendstoclaimaparticularmaterial
(e.g.:fluorosiliconeacrylate)oratype(e.g.:soft,air-permeablehardcontactlens(RGP))of
thecontactlensinrelationtotheeffectandefficacyofcontactlenscareproducts,anefficacy
testshallbeconductedforthematerialortypeofthepertinentcontactlens.
Ⅴ-tsthatareudfordecreasingthedesiretosmoke
Datatobe
1
submitted
Category
123
4
567Note
ABCDEFGH
Preparationcontainingnew
materials
○○○○○
△
○
△△△△
○○○
Mixedproductofnew
composition
○○○
△△
××××
△
×○○○
Content-varyingmixed
product
○○○
△
×××××
△
×
△
○○
Singleproduct○○○
△
×××××
△
×○○○
Newformulation○○○××××××××
△
○○
Newusagedirectionsand
do
○○×××××××××○○○
○:Datathatmustbesubmitted
△:Datathatmayberemittedbadonthejudgmentforindividualitems,becauthesubmissionis
notmeaningfulorpossible
×:Dataofwhichthesubmissionisremitted
Note1:DataNo.1through7refertothedatainsubparagraph1through7ofArticle23,andthe
toxicitydata(4)shallbeasfollows:
ncerningthetoxicity(forproductsthatareudbyinhaling,dataforatestthatis
carriedoutregardingtheproduct)
dotoxicitytestdata(forproductsthatareudbyinhaling,inhalationtoxicitytestdata)
62
eddotoxicitytestdata(forproductsthatareudbyinhaling,inhalation
toxicitytestdata)
uctiveanddevelopmentaltoxicitytestdata
xicitystudydata
toxicitytestdata
ogenicitytestdata
oxicitytestdata
encestudydata
63
Ⅴ-tsthatareinhaledinasimilarwayascigarettesandareudforaidingin
improvementofsmokinghabits
Datatobe
submitted
Category
1
123
4
567Note
ABCDEFGH
Newpreparations(including
changesinthekindsof
ingredients)
○○○△○△○△△△△△○○
Preparationofwhichthe
ingredientscontenthaschanged
○○
△△△
××××××
△
○○
○:Datathatmustbesubmitted
△:Datathatmayberemittedbadonthejudgmentforindividualitems,becauthesubmissionis
notmeaningfulorpossible
×:Dataofwhichthesubmissionisremitted
Note1:DataNo.1through7refertothedatainsubparagraph1through7ofArticle23,andthe
toxicitydata(4)shallbeasfollows:
ncerningthetoxicity
dotoxicitytestdata(inhalationtoxicitytestdata)
eddotoxicitytestdata(inhalationtoxicitytestdata)
uctiveanddevelopmentaltoxicitytestdata
xicitystudydata(applicableonlytothemicronucleustest)
toxicitytestdata
ogenicitytestdata
oxicitytestdata
encestudydata
64
Ⅵ.Disinfectantsforexternalu
Datatobe
1
submitted
Category
123
4
5Note267Note
ABCDEFG
Disinfectantsfor
ExternalU
○○○×××××××○○○
○:Datathatmustbesubmitted
△:Datathatmayberemittedbadonthejudgmentforindividualproducts,becauthe
submissionisnotmeaningfulorpossible
×:Dataofwhichthesubmissionisremitted
Note1:DataNo.1through7refertothedatainsubparagraph1through7ofArticle23
Note2:Referstotheefficacytestdata,andifthereisavalidreason,otherdatathatcanverifythe
efficacyandeffectmaybesubmitted.
65
Ⅶ.Productsaddedtowaterinsideahumidifiertopreventmicrobialgrowthorwaterresidues
Datatobe
1
submitted
Category
12Note23
4Note3
5Note567Note
ABCDEFGHNote4
Preparationcontaining
newmaterials
○○○○○
△
○
△△
○
△
○○○
Mixedproductofnew
composition
○○○
△△
××××
△
×○○○
Content-varyingmixed
product
○○○
△△
××××
△
×○○○
Singleproduct○○○
△△
××××
△
×○○○
Newformulation○○○
△△
××××××
△
○○
Newusagedirectionsand
do
○○×
△△
××××××○○○
○:Datathatmustbesubmitted
△:Datathatmayberemittedbadonthejudgmentforindividualitems,becauthesubmissionis
notmeaningfulorpossible
×:Dataofwhichthesubmissionisremitted
Note1:DataNo.1through7refertothedatainsubparagraph1through7ofArticle23,andthe
toxicitydata(4)shallbeasfollows:
tydata
dotoxicitytestdata(includinginhalationtoxicitytestdata)
eddotoxicitytestdata(includinginhalationtoxicitytestdata)
uctiveanddevelopmentaltoxicitytestdata
xicitystudydata
toxicitytestdata(includingskinnsitizationtestdata)
ogenicitytestdata
oxicitytestdata
xicitytestdata
66
Note2:Asphysicalandchemicaldata,aprofileinaphysicalformregardingthefinishedproduct,
suchasthechanges,articlesizeastheparticlesareemittedfromthehumidifier,
,asaconquence,itchangestoaformthatcanbeexpodtohuman
bodies,inhalationtoxicitytestdataaboutthefinishedproductshallbesubmitted.
Note3:Inthecaofsingledotoxicitytestdataorrepeateddotoxicitytestdata,inhalation
therepeateddotoxicitytest,periodof
administrationshallbe90days.
Note4:Ifitisaningredientthathasnotbeenudasanactiveingredientforthesterilizerofa
humidifier,itshallbeconsideredasanewmaterial,andamongthedataconcerningthe
toxicity,xicitytestshallexpothelungcell
for24hoursandcalculatetheconcentration(LC
50
)ofatestmaterialmanifestingthetoxicity.
Ifitshowsnotoxicityaccordingtotheinhalationtoxicitytestresult,itmayberemitted.
Note5:Referstotheefficacytestdataregardingthesterilizingpowerofaproductwhenitisadded
lverifytheeffectundertheconcentrationwithwhichtheproductis
eisavalidreason,otherdatathatcanverifytheefficacyandeffectmaybe
submitted.
67
[Appendix4]
ItemstoBeStatedforStandardsandTestMethods
(InRegardstoArticle27(1))
oBeStatedRawMaterialFinishedProduct
1Name○×
2StructuralformulaorRationalformula
△
×
3Molecularformulaandmolecularweight○×
4Originandmanufacturingmethod
△
×
5Contentstandards○○
6Appearance○○
7Confirmationtest○○
8
Materialproperty(Physicalandchemical
characteristics,etc.)
△△
9Puritytest○
△
10Lossondrying,lossonignition,ormoisture○
△
11Ignitionresidue,ashoracid-insolubleash
△
×
12Formulationtest×○
13OthertestsNote1△△
14
Quantification(contenttestforfinished
products)
○○
15Referencestandard,reagentandtestsolution
△△
○:Inprinciple,tobestated
△:Tobestatedifnecessary
×:Inprinciple,notneededtobestated
Note1:Othertestsincludemicrobiallimittest,sterilitytestforsterilizedproducts,andparticlesize
testforrawmaterials.
※Regardingpolymorphism,opticalactivity,etc.,properspecificationsshallbeestablishedinthe
itemssuchastheconfirmationtest,materialproperty(opticaldensity),puritytest,othertests
68
(isomerratio,abundanceratioofthecrystalform),quantificationmethod,ingon
thedetails.
69
[Appendix5]
ExampleofCompletedEnclodSpecificationsofRawMaterials(InRegardsto
Article29(1))
『KoreanName』
『EnglishName』
『StructuralFormula』
↑
Shingmyungjo,15point,Bold,CenterAligned
『Nickname』←12point,DividedAlignment→『Molecularformula:Molecularweight』
『OriginandRegulationsontheContent』
Thismedicationcontainsnolessthan99.0%of“Koreanname”(molecularformula:molecular
weight)foradriedmaterialthatisconvertedforquantifying.
ManufacturingMethod(ItemnamesshallbeJunggodic,13-pointfont,bold)
Appearance
Confirmationtest
MaterialProperty
PurityTest1)Dissolutionstatus
2)Afterweighingapproximately2.0gofaheavymetal,carryoutanoperationandatest
accordingtotheHeavyMetalTestMethodNo.2undertheGeneralTestMethodsintheKorean
ontrolsolution,add2.0mLofastandardleadsolution.(≤10ppm)
Lossondrying(Lossonignitionormoisture)
IgnitionResidue(AshorAcid-InsolubleAsh)
SpecialTest
Quantification
StorageMethod
Reagent,Testsolution
※DetailedPreparationGuidelines(matterstobenoted)
-upofpaper:PapersizeA4,Margin(top,bottom,header,footer12.5mm;rightandleft20mm)
70
aphformat:Linespacing180%,AlignmentFullyjustified
:ItshallbeFontShingmyungjo,Inter-letterspacing0%,Size12point.
71
[Appendix6]
ExampleofCompletedStandardsandTestMethodsforFinishedProducts(In
RegardstoArticle30(1))
Standards
ance(ItemnamesshallbewritteninJunggodic,13-pointfont,bold):OO(nameofthe
color)circularfilm-coatedpills
mationtest:Itshallcomplywiththistocarryoutatestaccordingtothefollowingtest
methods.
test:
neitytestforpreparations:
ttest:
Testmethod
ance:Visuallyobrve.
mationtest:
test:
neitytestforpreparations:
ttest:
※DetailedPreparationGuidelines(matterstobenoted)
-upofpaper:PapersizeA4,Margin(top,bottom,header,footer12.5mm;rightandleft20mm)
aphformat:Linespacing180%,AlignmentFullyjustified
:ItshallbeFontShingmyungjo,Inter-letterspacing0%,Size12point.
72
[Appendix7]
ScopeofSubmissionofDataforEvaluationofStandardsandTestMethods
(InRegardstoArticle31(1))
Datatobe
1
submitted
Category
12
34
ABCDEFANote2BCDE
ation
containingnew
materials
○○○○○○○○△○○○○
-drugof
whichthe
specifications,
amount,and
formulationofthe
mainingredientare
thesameasthoof
aproductwhichis
permittedalready
×
○
×××△○△△△△○△
-drugsthat
aremanufactured
accordingtothe
manufacturing
standardsNote3
△△×××△○△××△○△
preparationsNote4
○○
△Note5△Note5×○○
△Note5△△
○○
△Note5
○:Datathatmustbesubmitted
△:Datathatmayberemittedbadonthejudgmentforindividualitems,becauthesubmissionis
notmeaningfulorpossible
×:Datathatareremitted
Note1:DataNo.1through4refertothefollowingdata.
73
ordiscoveryandthedevelopment
asusagestatusdata
outrawmaterials
outthestructuraldetermination
outphysicochemicalcharacteristics
outmanufacturingmethods
tiarydataaboutstandardsandtestmethods
outtestreports
outreferencestandards,reagentsandtestsolutions
outfinishedproducts
outdrugsubstancesandtheamount
outmanufacturingmethods
tiarydataaboutstandardsandtestmethods
outtestreports
outreferencestandards,reagentsandtestsolutions
Note2:Ifthespecificationsofadditivesareenclodspecifications,evidentiarydataaboutspecificationsof
excipientsshallbesubmitted.
Note3:ItemsthatfallundertheprovisotoArticle5(2)shallbeexcluded.
Note4:"Otherpreparations"meansquasi-drugsthatdonotfallunderArticles1through3and
correspondtoanewformulation,newcompositionofmainingredients,adjustedcontent,
isomer,mineralchanges,mparedwithquasi-drugsthatarepermittedalready.
Note5:Tobesubmittedwhentherearechangesinisomerandsaltoftherawingredient.
74
[Appendix8]
ScopeofSubmissionofDataforSafetyandEfficacyevaluationofInfectiousDia-
PreventiveDisinfectantsandIncticides
(InRegardstoArticle46(1))
Datatobe
submitted
Category
1
1
2
3
4Note2
567,8
ABCNote3ABCDEF
G
123
1)Infectiousdia-preventive
disinfectantsandincticides
containingnewmaterials
○○○○○○○○○△△○○○○○○
2)Itemthatdiffersfromtheitem
whichisalreadypermittedasan
infectiousdia-preventive
disinfectantandincticideinat
leastoneofthefollowingaspects
-ingredientcomposition(active
ingredientanditsconcentration),
efficacyandeffect,usage
directionsanddo,and
formulation
○××○○
○△×××△△△△○
×
○
3)Itemofwhichthe
specifications,amount,and
formulationoftheingredientthat
affectstheeffect,suchasthe
activeingredient,effectenhancer,
etc.,arethesameasthoofan
itemwhichispermittedalready
Note4
×
××○
××××××××××××
○
○:Datathatmustbesubmitted.
△:Datathatmayberemittedbadonthejudgmentforindividualproducts,becauthesubmissionisnotmeaningful
75
orpossible.
×:Dataofwhichthesubmissionisremitted.
Note1:DataNo.1through8refertothedatainsubparagraphs1through8ofArticle45.
Note2:Ingeneral,toxicitydata(4)shallbethedatatestedforthemainingredient,andthesingle
dotoxicitytestdataandfishtoxicitytestdatashallbeadditionallysubmittedforthe
toxicitytestdataamongthedatainclau(f)andresiduetestdata
amongthedatainclau(g)maybesubmittednotonlythroughdataformainingredients,
butalsothroughdataforpreparations.
Note3:Inthecaoftheincticides,primarytestdatathathavebeenpreparedaccordingtothe
standardsandtestmethodsformainingredientsshallbeadditionallysubmitted.
Note4:Aproductofwhichthespecificationsoftheingredientthataffectstheeffect,suchasthe
activeingredient,effectenhancer,etc.,arethesameasthooftheproductwhichhasbeen
permittedalreadymeansthatamongthepertinentingredient’sspecifications,contentand
flexiblematerialsstandardsarethesameorhigherthanthoofanalreadypermittedproduct.
76
[AnnexFormNo.1]
DatatobeSubmittedfortheSafetyandEfficacyEvaluation(ExcludingInfectiousDia-
PreventiveDisinfectantsandIncticides)(InRegardstoArticle22)
*berinArticle23andeachsubparagraphofAppendix3.
New
Additive
DataNo.1234
berineach
subparagraphofArticle24
(3).
Submission
status
Quasi-
Drugs
Ⅰ,Ⅱ,Ⅵ
Data
No.
123
4
567
ber
inArticle22and
Appendix3I,II,VI.
ABCDEFG
Submi
ssion
status
Quasi-
DrugsⅢ
Data
No.
123
45
67
numberin
Article22and
Appendix3III.
ABCDEFGABC
Submi
ssion
status
Quasi-Drugs
Ⅳ
Data
No.
123
45
67
ber
inArticle22and
ABCDEAB
77
Submi
ssion
status
Appendix3IV.
Quasi-
DrugsⅤ
Data
No.
123
4
567
numberinArticle
22andAppendix3
V.
ABCDEFGH
Submi
ssion
status
78
[AnnexFormNo.2]
DatatobeSubmittedfortheSafetyandEfficacyEvaluationofInfectiousDia-Preventive
DisinfectantsandIncticides)(InRegardstoArticle44)
*umbercorrespondingtoeachsubparagraphofArticle45andAppendix8.
Infectious
dia-
preventive
disinfectants
and
incticides
DataNo.1
2
3
4
567.8
ABCABCDEF
G
123
Submission
status
79
[AnnexFormNo.3]
ExampleofCompletedSummaryofIncticidalandDisinfectionPowerTest
(InRegardstoArticle47)
the
Incticide
(forspraying)
Ingredient
Per1kgor1L
NameoftheIngredient(Amount)g
Experiment
l
Inctunder
Consideration
Scientificnameofthehygienicharmfulinct
of
Experiment
onofcollection
ofcollection
ofrearing
thod
izeandstatethenumberofharmfulinctssubjectedtothetest,
area,concentrationoftheincticidesud,methodofapplication,
time,fatalityrate,etc.
lgroup
of
Experiment
Incticide
Concentration
(%)
Dilution
Ratio
(X)
Total
Abundance
(numberof
incts)
Fatalities
(numberof
incts)
FatalityRate
(%)
TestGroup
80
ControlGroup
endedUsage
Directions
sconcerningthe
TestingOrganization
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