藥品說(shuō)明書(shū)、標(biāo)簽的管理規(guī)定英文翻譯

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

2、 same 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.1 For standardizing the administration for the insert and packaging labels of drug on the basis of “Drug Administration l

3、aw otfh e P. R. of China ” andR e“gulations 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

4、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 p

5、rinted 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

6、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

7、 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

8、 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 phar

9、maceutical 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 insertNo.9 Drug's insert should contain the important and scientific d

10、ata, 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 spe

11、cialized nouns, drug name, clinical test names and results in the dru'gs 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.11 All the APIs or crude drugs in the formula to be

12、 listed in the drug's insert. All the excipients for the injection and OTC drugs are also to be listed in the insert.That's to be indicated if the formula contains the ingredient(s) or excipient(s) which may cause a serious adverse reaction.No.12 The pharmaceutical manufacturer should track

13、forwardly the safety and efficacy status of drug post market, and should raise the application in time for the modification of drug's 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 man

14、ufacturer to modify the dru'gs insert.No.13 The pharmaceutical manufacturer should 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 t

15、ime as per the requirements.No.14 Drug's insert should contain enough information of adverse 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

16、or didn 't indicate enough the adverse reactions of drug in the insert, the harmful result caused to be borne by relevant manufacturer.No.15 The approval date and revised date of dru'gs insert to be indicated clearly in the insert.Section III Labels of drugNo.16 The labels of drug refer to t

17、he 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 used for immediate pack, and the outer label refers to that labels used for other packs except internal label.No.17 The internal label of drug should

18、 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, strengt

19、h, batch No., expiry date etc. should be indicated. No.18 The outer label of drug should indicate the contents of the generic name of drug, ingredient(s), description, indications or efficacy, strength, dosage and administration, adverse reactions, contraindication, warnings & precautions, stora

20、ge, mfg date, batch No. permission No., manufacturer etc. If the full contents of indications or efficacy, dosage and administration, adverse reactions, contraindication and warnings & precautions ca'nt be able to be covered, then the major contents to be indicated and note“ that details are

21、 exhibited in the insert”.No.19 Shipper 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.20 Th

22、e 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.21 For the same drug with same strength and pack size from the same phar

23、maceutical 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 w

24、ell as OTC drug, the color for both packages should be clearly distinguished respectively.No.22 For the drug which storage has special requirement, the storage to be indicated in a striking place of the label.No.23 The expiry date in the label of drug should be labeled as per the sequence of year-mo

25、nth- date, the year is expressed as 4 numerals, the month and the date is expressed 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

26、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.

27、 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 i

28、nitial date.Section IV Use of drug name and registered trademarkNo.24 The drug name labeled in the insert 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.25 The generic name of drug

29、 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 b

30、e 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 character can't be selected, and the font ca'nt be modified with italic, central emptily, hatching forms etc.(3) The color of font should be black or white, to

31、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.No.26 The brand name can't 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.27 The trademark which is not registered and other drug name which is not approved by SFDA are inhibitive to be used for the inse