药品说明书、标签管理规定的英文翻译.doc

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1、Administrative Regulation for Insert and packaging Labels of drug(SFDA Order No.24)State Food and Drug Administration OrderNo.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 sam

2、e to be implemented since June 1st, 2006.SFDA Director: Shao Ming LiMar. 15, 2006Administrative Regulation for the Insert and Packaging Labels of DrugSection IGeneral rulesNo.1For standardizing the administration for the insert and packaging labels of drug on the basis of “Drug Administration law of

3、 the P. R. of China” and “Regulations for Implementation of the Drug Administration Law of the P. R. of China”.No.2Relevant inserts and packaging labels for all the drugs which are sold in china to be in line with the requirements from present regulation.No.3The Inserts and packaging labels of drugs

4、 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.4The label should be printed or

5、 stickled on the package for drug as per relevant regulations, and cant 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.5Th

6、e text expression for drugs 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.6The text of drugs insert and labels should be clear and

7、 easy to be differentiated, the mark should be clear and striking, the appearance with dropping words or unstick etc. should not appear, and cant be modified or supplemented by sticking, cutting or altering.No.7The standard Ch. Character published by State Spoken and Written Language Committee shoul

8、d 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.8For 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

9、 forwardly to add the warnings on the drugs insert or labels, SFDA also may require relevant pharmaceutical manufacturer to add the warnings on the insert or labels.Section IIDrugs insertNo.9Drugs insert should contain the important and scientific data, results and information about the safety and e

10、fficacy of drug, so that can be able to guide the safe and rational uses of drug. The detail format, contents and written requirement for drugs insert are drafted and issued by SFDA.No.10The expression of the disease names, pharmaceutical specialized nouns, drug name, clinical test names and results

11、 in the drugs 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.No.11All the APIs or crude drugs in the formula to be listed in the drugs insert. All the excipients for the injectio

12、n and OTC drugs are also to be listed in the insert.Thats to be indicated if the formula contains the ingredient(s) or excipient(s) which may cause a serious adverse reaction.No.12The pharmaceutical manufacturer should track forwardly the safety and efficacy status of drug post market, and should ra

13、ise the application in time for the modification of drugs insert if necessary.According to the monitor results for the adverse reactions of drug and the re-evaluation of drug, SFDA also may require the pharmaceutical manufacturer to modify the drugs insert.No.13The pharmaceutical manufacturer should

14、 inform the modified contents to relevant pharmaceutical business companies, used units and the concerned depts. immediately after the modified insert was approved, and implement the modified insert and labels in time as per the requirements.No.14Drugs insert should contain enough information of adv

15、erse reactions of drug, and indicate the adverse reactions in detail. If the pharmaceutical manufacturer had not modified the insert in time on the basis of the safety and efficacy status of drug post market or didnt indicate enough the adverse reactions of drug in the insert, the harmful result cau

16、sed to be borne by relevant manufacturer.No.15The approval date and revised date of drugs insert to be indicated clearly in the insert.Section IIILabels of drugNo.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 la

17、bel. The internal label refers to that label used for immediate pack, and the outer label refers to that labels used 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

18、, mfg date, batch No. expiry date, manufacturer etc.If the pack size is too small and cant 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

19、the generic name of drug, ingredient(s), description, indications or efficacy, strength, dosage and administration, adverse reactions, contraindication, warnings & precautions, storage, mfg date, batch No. permission No., manufacturer etc. If the full contents of indications or efficacy, dosage and

20、administration, adverse reactions, contraindication and warnings & precautions cant be able to be covered, then the major contents to be indicated and note “that details are exhibited in the insert”.No.19Shipper label should indicate the necessary contents of the generic name of drug, strength, stor

21、age, 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.

22、, 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 sh

23、ould 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 spec

24、ial 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 sequence of year-month-date, the year is expressed as 4 numerals, the month and the date is expressed as 2 numerals respectively. The detail format is

25、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 specifica

26、tion. 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 agai

27、nst 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 IVUse of drug name and registered trademarkNo.24The drug name labeled in the insert and labels should be in line with

28、 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 horizo

29、ntal 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, seal characte

30、r cant be selected, and the font cant 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 cant be written in different rows except the pack size is too small

31、 and the full name cant be exhibited.No.26The brand name cant be set 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

32、 which is not registered and other drug name which is not approved by SFDA are inhibitive to be used for the insert and labels of drug.The registered trademark which is used for drug label should be printed in the side corner of drug label, if it contains the character, then the area of single font

33、is not more than the quadrant area of the generic name.Section VOther regulationNo.28For the anaesthetic, psychoactive, medical toxicity drug, radioactive drug and the drug for exterior use and OTC etc. which has special mark issued by state, their inserts and labels should print the special mark. T

34、he insert and labels which have special requirement will be identified by SFDA.No.29The administrative regulation for the labels of crude Chinese traditional medicine or dry pieces will be drafted by SFDA by supplementary document.No.30The insert and labels of drug which didnt complied with this regulation to be punished as per relevant requirements Drug Administration law of the P. R. of China.Section VISupplementary articlesNo.31This regulation will be implemented since June 01, 2006. The SFDA Order No.23 issued by Oct 15, 2000 will be disused synchronously.