药品说明书、标签的管理规定英文翻译
Administrative Regulation for Inrt and packaging Labels of drug
古木参天(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.
SFDA Director: Shao Ming Li
Mar. 15, 2006 Administrative Regulation for the Inrt and Packaging Labels of Drug
Section I General rules
五香豆腐干
No.1 For 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.2 Relevant inrts and packaging labels for all the drugs which are sold in china to be in line with the requirements from prent regulation.
No.3 The 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.4 The 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 in
高级筛选rt.
No.5 The 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.
拾金不昧的故事面如土色的意思No.6 The 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.7 The 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.8 For 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.9 Drug’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.ceeport
No.10 The 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.11 All the APIs or crude drugs in the formula to be listed in the drug’s inrt. All the ex
cipients 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.
羊杂面的做法
口腔科医生No.12 The 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.13 The 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.14 Drug’s inrt should contain enough information of adver reactions of drug, and i
ndicate 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.
