药品说明书、标签管理规定的英文翻译

Administrative Regulation for Insert and packaging Labels of drug

(SFDA Order No.24)

State Food and Drug Administration Order

No.24

“Administrative Regulation for Insert 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 Insert and Packaging Labels of Drug

Section I General rules

No.1 For standardizing the administration for the insert 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 inserts and packaging labels for all the drugs which are sold in china to be in line with the requirements from present regulation.

No.3 The Inserts and packaging labels of drugs should be approved by SFDA.

The packaging labels of drugs to be drafted as per the insert, their text should not exceed the range of insert, and should not contain the character and mark which suggests the efficacy, mislead uses 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 insert.

No.5 The text expression for drug’s insert and labels should be scientific, standard and accurate.

The text expression for the insert for OTC drug should be easy for understanding for the patients whom could be able to self judges, selects and uses.

No.6 The text of drug’s insert 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 used for the insert and labels of drug, the Ch. Character expression will be the criterion when has additional other language for reference.

No.8 For the purpose of protecting the public health and guiding the drug to be used by a right and rational way, the pharmaceutical manufacturer may raises forwardly to add the warnings on the drug’s insert or labels, SFDA also may require relevant pharmaceutical manufacturer to add the warnings on the insert or labels.

Section II Drug’s insert

No.9 Drug’s insert 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 uses of drug.

The detail format, contents and written requirement for drug’s insert are drafted and issued by SFDA.

No.10 The expression of the disease names, pharmaceutical specialized nouns, drug name, clinical test names and results in the drug’s insert should use 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.