Regulation on Drug Insert Sheet and Label(SFDA 24 Order)

REGULATION ON DRUG INSERT SHEET AND LABEL(SFDA order 24)Order no. 24 from State Food and Drug Administration (SFDA) Regulation on Drug Insert Sheet And Label was approved during the directors meeting of SFDA on March 10, 2006, and is hereby published. This Regulation shall become effective from June 1, 2006.Shao Mingli.Commissioner,State Food and Drug AdministrationMarch 15, 2006 REGULATION ON DRUG INSERT SHEET AND LABELChapter 1: General PrinciplesArticle 1:This Regulation is promulgated in accordance with Drug Administration Law of T he People’s Republic of China (Drug Administration Law) and the Implementing Regulation of the Drug Administration Law of T he People’s Republic of China (Implementing Regulation), to standardize the administration of drug insert sheets and labels.Article 2:Insert sheet and label of the drugs marketed within The People’s Republic of China should comply with the provision of this Regulation.Article 3:Drug insert sheet and label should be confirm by SFDA.A drug label should be based on the insert sheet, the contents should not exceed the scope of insert sheet. Wording and logo should not imply efficacy, so as to come misapplication or inappropriate promotion.Article 4:Drug packing must be attached or affixed with label according to the applicable regulation, but should not be attached with any other description in writing or in video or audio or other form to introduce the product or the manufacturer.The smallest retail packing available in the market from the manufacturer should be attached with insert sheet.Article 5:Wording of the drug insert sheet and label should be scientific, standardized, and accurate. The wording of insert sheet for OTC drugshould be described in simple wording easy to understand, in order for patient to independently judge, choose and use.Article 6:Text printed in the drug insert sheet and label should be clear and concise, with conspicuous identification. There should not be any missing printed characters or loosely affixed label, and no alteration or supplementing by posting, cutting or removal is allowed.Article 7:Chinese characters used in drug insert sheets or labels should be from the standardized characters published by the National Language and Character Committee, and the Chinese description is the standard language. Article 8:In order to protect public health and guide the correct use of drug, drug manufacturer may voluntarily offer to add warning language in the insert sheet or label. SFDA may also request the manufacturer to add warning statement in the insert sheet or label.Chapter 2: Drug Insert SheetArticle 9:The drug insert sheet should include the important scientific data, conclusion and information related to drug safety and efficacy to guide the safe and reasonable use of drug. The specific form, content and wording of drug insert sheet shall be promulgated and published by SFDA.Article 10:Name of diseases, pharmaceutical term, drug name, expression of term and result of clinical trials referenced in the drug insert sheet should be from the special terminology uniformly published or standardized by the State, while the unit of measure should comply with National Standards.Article 11:The drug insert sheet or label should provide a list of all active ingredients, or all TCM within the formulas. The list of all active ingredients and excipients should also be provided for injection and OTC drugs. For components or excipients which when prescribed could cause serious adverse reactions, this should be noted.Article 12:The drug manufacturer should voluntarily monitor post marketing safety and efficacy of the drug, and, when necessary, timely file application for updating of drug insert sheet. Based on the information from adverse drug reaction monitoring and drug re-valuation, SFDA may also request the manufacturer to update the drug insert sheet.Article 13:After obtaining the approval of updated drug insert sheet, drug manufacturer should notify the related drug operation business, drug users and other related entity of the updating of the new insert sheet, andtimely switch into the updated insert sheet according to the requirements. Article 14:Insert sheets should include sufficient information about the adverse drug reaction (ADR), with detailed notes about the reactions. Drug manufacturer should be liable for the consequences of failing to timely update the insert sheet based on the post marketing drug safety and efficacy or failure to provide sufficient ADR notes in the insert sheet.Article 15:Approval date and updating date of the insert sheet should be conspicuously marked in the insert sheet.Chapter 3: Drug LabelArticle 16:The drug label refers to the text that affixed or printed with the drug packing, and includes internal label and external label, where internal label refer to the label attaching with immediate packing of the drug and external label refer to the label of the packing other than the internal label.Article 17:The internal label should contain information of drug INN, indication, strength, dosage, manufacture date, batch number, validity period, and name of manufacturer. Where the packing is too small to contain all the information, drug INN, strength, batch number, validity period should be included, as a minimum.Article 18:The external label should note the information of drug INN, ingredient, identity, indication, strength, dosage, adverse reaction, contraindication, notes, storage, manufacture date, batch number, validity period, approval number, and manufacturer. If the information about indication, dosage, adverse reaction, contraindication and notes cannot be fully explained, major content should be included with notes that “see insert sheet for detailed information”.Article 19:The label for packing used for transportation and storage should at a minimum include the information of drug INN, strength, storage, manufacture date, batch number, validity period, approval number, and manufacturer, and, if necessary, may note packed quantity, notes for transportation and other necessary notes.Article 20:The label for raw materials should note the information of drug name, storage, manufacture date, batch number, validity period, applicable standards, approval number, and manufacturer, and also the packed quantity, notes for transportation and other necessary information. Article 21:For the same drugs manufactured by the same manufacturer, ifthe drugs are identical in both drug strength and packing presentation, then the content, form and color of the drug label must be consistent. If the there is any difference in drug strength and packing presentation, the labels should be clearly distinguished from each other, or there should be obvious difference when identifying the strength.If the same drugs manufactured by the same manufacturer are administered under category of prescription and OTC drug respectively, there should be obvious difference in the color used for the label of the two drugs.Article 22:In the case of any special conditions for storage, the conditions should be clearly marked on the label.Article 23:The validity period should be printed on the label in the format of year, month and day, with 4 digits for year, 2 digits for month and day. The s pecific format should be “valid till xxxx year, xx month” or “valid till xxxx year xx month xx day, while other combination of digit or symbol may be used such as “valid till xxxx.xx” or “valid till xxxx/xx/xx”. Registration standards approved by SFDA shall apply to the format of the validity period of biological products. The validity period of therapeutic biological product should start from the date of packing, while the validity period of preventive biological products should from date of manufacture. When the validity period is in days, the starting date should the preceding day of corresponding period, and if the period is in month, the starting month should the preceding month of corresponding period.Chapter 4: Use of Drug Name and TrademarkArticle 24:Drug name referred in drug insert sheet and label must comply with nomenclature of drug INN and trade name published by SFDA, and be consistent with the corresponding section of the drug approval document.Article 25:Drug INN name should be conspicuous and at the focal point and there should be consistency between font, size and color of character with compliance with the following.1.For horizontal text orientation, text should placed conspicuously bein the upper 1/3 section. For vertical text orientation, text should placed conspicuously be at the right 1/3 section.2.Fonts which are difficult to recognize such as font of Chinese Kaiand Zhuan must not be used, no pattern of italic, hollow, shaded should be used to format the text.3.Color of the text should be in black or white, to have strong contrasteffect with the light or dark background.4.No word wrap is allowed except for when the width is limited due tosize of the packing.Article 26:Drug trade name should not be printed in the same line with drug INN name. The font of the trade name should not be more conspicuous or highlighted than the INN name. The area of single character of the trade name should not exceed 1/2 of that of the INN name. Article 27:No unregistered trademark or other drug name not approved by SFDA should be used in the drug insert sheet or label.The trademark, if used in label, should be printed at the margin of the drug label, and the area of single character of text, if used, should not exceed 1/4 of that of the INN name.Chapter 5: MiscellaneousArticle 28:When there is statutory requirement for special marks in the cases such as narcotics, psychotropic, medical-use toxic drugs, radioactive drugs, external use drug, and OTC drugs, the required special marks must be printed in the insert sheet and label.When there are statutory special provisions for insert sheet or label, those provisions should be applicable.Article 29:Regulations for TCM raw material or TCM herbs should be promulgated separately by SFDA.Article 30:Sanctions should be imposed according to the applicable provision of Drug Administration Law of T he People’s Republic of China in the event of non-compliance of insert sheet or label with this Regulation.Chapter 6: MiscellaneousArticle 31:This Regulation shall take effect from June 1, 2006, while the Regulation On Drug Packing, Label And Insert Sheet (temporary) published by SDA on October 15, 2000 should be abolished accordingly.End。