药品说明书、标签管理规定的英文翻译

更新时间:2023-05-19 09:17:20 阅读: 评论:0

Administrative Regulation for Inrt and packaging Labels of drug
(SFDA Order No.24)
State Food and Drug Administration Order
No.24
“Administrative Regulation for Inrt and packaging Labels of Drug” had been evaluated & agreed by the management meeting of SFDA by Mar.10, 2006, and publish here, the same to be implemented since June 1st, 2006.
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浮躁怎么办Mar. 15, 2006 Administrative Regulation for the Inrt and Packaging Labels of Drug
integrateSection I General rules
No.1For standardizing the administration for the inrt and packaging labels of drug on the basis of “Drug Administration law of the P. R. of China” and “Regulations for Implementation of the Drug Administration Law of the P. R. of China”.
No.2Relevant inrts and packaging labels for all the drugs which are sold in china to be in line with the requirements from prent regulation.
No.3The Inrts and packaging labels of drugs should be approved by SFDA.
The packaging labels of drugs to be drafted as per the inrt, their text should not exceed the range of inrt, and should not contain the character and mark which suggests the efficacy, mislead us and unsuitable publicity the product.
No.4The label should be printed or stickled on the package for drug as per relevant regulations, and can’t carry any other character, audiovisual, or material for introduction or publication propaganda for product and / or manufacturer.
The smallest pack sold in market from the pharmaceutical manufacturer should contain inrt.
No.5The text expression for drug’s inrt and labels should be scientific, standard and accurate.
The text expression for the inrt for OTC drug should be easy for understanding for the patients whom could be able to lf judges, lects and us.
No.6The text of drug’s inrt and labels should be clear and easy to be differentiated, the mark should be clear and striking, the appearance with dropping words or unstick etc. should not appear, and can't be modified or supplemented by sticking, cutting or altering.
No.7The standard Ch. Character published by State Spoken and Written Language Committee should be ud for the inrt and labels of drug, the Ch. Character expression will be the criterion when has additional other language for reference.
No.8For the purpo of protecting the public health and guiding the drug to be ud by a right and rational way, the pharmaceutical manufacturer may rais forwardly to add the warnings on the drug’s inrt or labels, SFDA also may require relevant pharmaceutical manufacturer to add the warnings on the inrt or labels.
Section II Drug’s inrt
No.9Drug’s inrt should contain the important and scientific data, results and information about the safety and efficacy of drug, so that can be able to guide the safe and rational us of drug.
The detail format, contents and written requirement for drug’s inrt are drafted and issued by SFDA.
No.10The expression of the dia names, pharmaceutical specialized nouns, drug name, clinical test names and results in the drug’s inrt should u the special and standard vocabulary or that one issued by state, and the weights and measures to be in line with the requirements of national standard.
No.11All the APIs or crude drugs in the formula to be listed in the drug’s inrt. All the excipients for the injection and OTC drugs are also to be listed in the inrt.
That’s to be indicated if the formula contains the ingredient(s) or excipient(s) which may cau a rious adver reaction.
No.12The pharmaceutical manufacturer should track forwardly the safety and efficacy status of drug post market, and should rai the application in time for the modification of drug’s inrt if necessary.
According to the monitor results for the adver reactions of drug and the re-evaluation of drug, SFDA also may require the pharmaceutical manufacturer to modify the drug’s inrt. No.13The pharmaceutical manufacturer should inform the modified contents to relevant pharmaceutical business companies, ud units and the concerned depts. immediately after the modified inrt was approved, and implement the modified inrt and labels in time as per the requirements.
No.14Drug’s inrt should contain enough information of adver reactions of drug, and indicate the adver reactions in detail. If the pharmaceutical manufacturer had not modified the inrt in time on the basis of the safety and efficacy status of drug post market or didn’t indicate enough the adver reactions of drug in the inrt, the harmful result caud to be borne by relevant manufacturer.
No.15The approval date and revid date of drug’s inrt to be indicated clearly in the inrt.
Section III Labels of drug
No.16The labels of drug refer to the contents which are printed or pasted in the package of drug, it divides into internal label or outer label. The internal label refers to that label ud for immediate pack, and the outer label refers to that labels ud for other packs except internal label.
No.17The internal label of drug should contain the contents of generic name, indications or efficacy, strength, dosage and administration of drug, mfg date, batch No. expiry date, manufacturer etc.
If the pack size is too small and can’t be able to cover all the contents above, at least, that contents of generic name of drug, strength, batch No., expiry date etc. should be indicated. No.18The outer label of drug should indicate the contents of the generic name of drug, ingredient(s), description, indi
cations or efficacy, strength, dosage and administration, adver reactions, contraindication, warnings & precautions, storage, mfg date, batch No.
permission No., manufacturer etc. If the full contents of indications or efficacy, dosage and administration, adver reactions, contraindication and warnings & precautions can’t be able to be covered, then the major contents to be indicated and note “that details are exhibited in the inrt”.
No.19Shipper label should indicate the necessary contents of the generic name of drug, strength, storage, mfg date, batch No., expiry date, permission No., manufacturer etc., also may indicate the package quantity and transport warnings and other mark if necessary.
No.20The label for API should indicate the necessary contents of drug name, storage, mfg date, batch No., expiry date, specification No., permission No., manufacturer etc., and also indicate the pack side and the transport warnings.
No.21For the same drug with same strength and pack size from the same pharmaceutical manufacturer, the text, format and color of the label to be same, for the different strength or pack size, the label should be clearly different or the strength to be indicated clearly.
The same drug from the same pharmaceutical manufacturer which is administered for prescription drug as well as OTC drug, the color for both packages should be clearly distinguished respectively.
No.22For the drug which storage has special requirement, the storage to be indicated in a striking place of the label.
No.23The expiry date in the label of drug should be labeled as per the quence of year-month-date, the year is expresd as 4 numerals, the month and the date is expresd as 2 numerals respectively. The detail format is labeled as expiry by “XXXX year XX month” or “expiry by XXXX year XX month XX date”, also may be labeled as “expiry by XXXX.XX.” or “expiry by XXXX/XX/XX” etc. with the numeral or other symbol.
The expiry period for preventative biological products should be labeled as per the SFDA approval specification. For the biological products for treatment, the expiry period to be counted since the repackaging date, but for other drugs, that to be counted since mfg. Date.
If the expiry period is labeled up to the date, then the expiry date should be the previous date corresponding the year-month-date against the initial date. If the expiry period is labeled up to the month, then the expiry date should be the previous month corresponding the year-month against the
initial date.
Section IV U of drug name and registered trademark
No.24The drug name labeled in the inrt and labels should be in line with the nominated principle for drug generic name and brand name which is issued by SFDA, and identical with the approval certificate.
No.25The generic name of drug should be notable and outstanding, its font, size and color should be accordant, and in line with the requirements below:
(1)For the horizontal label, the generic name of drug should be exhibited within the upper
third area at a marked place.
For the standing label, the generic name of drug should be exhibited within the third area
of right at a marked place.
(2)The font which is not easy to be identified, i.e. grass hand, al character can’t be
starpad
lected, and the font can’t be modified with italic, central emptily, hatching forms etc.
(3)The color of font should be black or white, to produce a strong contrast against the tint
or dark background.
(4)The generic name can’t be written in different rows except the pack size is too small and
the full name can’t be exhibited.
nootbookNo.26The brand name can’t be t in the same row with the generic name, the font and color of brand name is not more extrusive and distinct than the generic name, the area of single font is not more than the half area of the font of generic name.
No.27The trademark which is not registered and other drug name which is not approved by SFDA are inhibitive to be ud for the inrt and labels of drug.d unit
The registered trademark which is ud for drug label should be printed in the side corner
of drug label, if it contains the character, then the area of single font is not more than the
quadrant area of the generic name.
Section V Other regulation
2009年英语四级成绩查询No.28For the anaesthetic, psychoactive, medical toxicity drug, radioactive drug and the drug for exterior u and OTC etc. which has special mark issued by state, their inrts and labels
should print the special mark. The inrt and labels which have special requirement will be identified by SFDA.
No.29The administrative regulation for the labels of crude Chine traditional medicine or dry pieces will be drafted by SFDA by supplementary document.
thrilledNo.30The inrt and labels of drug which didn’t complied with this regulation to be punished as per relevant requirements Drug Administration law of the P. R. of China.
bruid
Section VI Supplementary articles
No.31This regulation will be implemented since June 01, 2006. The SFDA Order No.23 issued by Oct 15, 2000 will be disud synchronously.

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