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China's new Regulation for the Administration of Drug Packaging includes significant changes from the previous rule.
The Chinese State Food and Drug Administration (SFDA) issued its new "Regulation for the Administration of Drug Packaging, Labels and Insert Sheets" on March 10, which went into effect on June 1, 2006. The new regulation includes significant changes from the previous temporary rule.
According to SFDA statistics, most generic drug packages carry a trade name. Some manufacturers have abused trade names to the extent of mislabeling drugs to mimic new products and claim increased efficacy (at increased prices). SFDA imposed the new rule to counteract such abuses.
The new regulation requires that the use of drug trade names strictly comply with Provisions for Drug Registration. Only products that contain the specified new chemical structures, new active ingredients, or conform to the formulation of patented chemical compound drugs may use the trade name. Moreover, manufacturers must use the same trade name to identify all dosage forms and dosage strengths of a given product (rather than creating a new brand for each version of the product). Trade names should not be used independently in drug advertisements. And, character-type trademarks that have not been approved to be trade names are not allowed in drug advertisements.
The new regulation requires that product trade names be in Chinese, rather than consist of pictures, Roman letters, numbers, or other symbols. And, trade names may not contain words specifically prohibited under Chinese Trade Mark Law.
In addition, the new label regulation prohibits including marketing claims on the label such as:
The new rules further require that the generic name in China must be clearly marked on drug packaging and that the type size of the trade name shall be no more than half as large as the generic name. The rule includes detailed requirements for type positions, fonts, and background colors. Registered trademarks, if applicable, shall be printed in the corner of the label and the size of each character of the registered trademark shall not exceed one-fourth of the generic name.The Provisions prohibit using any unregistered trademark or drug names on labels or drug inserts that have not been approved by SFDA.
Furthermore, the Provisions require that drug insert sheets shall contain critical scientific data, conclusions and information on the safety and effectiveness of the drug to guide safe, rational drug use by consumers. Drug insert sheets shall provide full information on adverse drug reactions, and drug manufacturers shall revise drug insert sheets according to postmarking evaluation of safety and effectiveness in a timely. Manufacturers that fail to comply will be held responsible for any adverse consequences. The Provisions also require that even the smallest retail packaging units shall bear insert sheets.
Drug manufacturers must now file supplementary applications to alter trade names. SFDA will not approve the applications for trade names that do not comply with the new rule. Drugs with old-style labeling and packaging may continue to be sold if the labeling was approved before June 1, 2006 and the drug is produced before June 1, 2007. After that date, all drug labels and insert sheets must follow the new regulation.
Kong Liang is a project manager at APEX China Co., Ltd., Room 202, No. 2, Lane 418, Mudan Road, Shanghai, 201203, China, firstname.lastname@example.org
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