Pharmaceutical Packaging Printing Standards Remain Unchanged

It is learned from the State Food and Drug Administration, the Registration Division and the Market Division of the Beijing Municipal Food and Drug Administration, the Beijing Institute for the Inspection of Pharmaceutical Packaging Materials and other relevant institutions that the printing standard for printing packaging materials, namely printed matter (outer package inserts and labels for drugs), is still implemented in accordance with the "Provisions for the Administration of Drug Package Inserts and Labels" promulgated on 15 March 2006 (i.e. Order No. 24 of the State Food and Drug Administration).

Relevant printing standard policies:

Order No. 24 of the State Food and Drug Administration, the "Provisions for the Administration of Drug Package Inserts and Labels", was deliberated and adopted at the administrative affairs meeting of the State Food and Drug Administration on 10 March 2006, is hereby promulgated, and comes into force as of 1 June 2006.

Article 1 These Provisions are formulated in accordance with the "Drug Administration Law of the People's Republic of China" and the "Implementing Regulations of the Drug Administration Law of the People's Republic of China" in order to regulate the administration of drug package inserts and labels.

Article 2 Drugs marketed and sold within the territory of the People's Republic of China shall have package inserts and labels that comply with the requirements of these Provisions.

Article 3 Drug package inserts and labels shall be approved by the State Food and Drug Administration.

Drug labels shall be based on the package insert; their content shall not go beyond the scope of the package insert, and they shall not bear words or marks that imply therapeutic effect, mislead use or inappropriately promote the product.

Article 4 Drug packaging must bear printed or affixed labels in accordance with these Provisions, and shall not contain any other text, audio-visual or other materials introducing or promoting the product or the enterprise. Small packages produced by drug manufacturers for marketing and sale must be accompanied by a package insert.

Article 5 The wording of drug package inserts and labels shall be scientific, standardised and accurate. Package inserts for over-the-counter drugs shall also use wording that is easy to understand, so that patients can judge, select and use the drug themselves.

Article 6 The text in drug package inserts and labels shall be clear and easy to distinguish, and the marks shall be distinct and eye-catching. There shall be no phenomena such as print falling off or insecure adhesion, and no modification or supplementation may be made by means of pasting, cutting or altering.

Article 7 Drug package inserts and labels shall use the standardised Chinese characters promulgated by the State Language Commission; where other scripts are added for reference, the Chinese character text shall prevail.

Article 8 For the purpose of protecting public health and guiding accurate and rational drug use, drug manufacturers may on their own initiative propose to add warning statements to drug package inserts or labels, and the State Food and Drug Administration may also require drug manufacturers to add warning statements to package inserts or labels.

Chapter II Drug Package Inserts

Article 9 Drug package inserts shall contain important scientific data, conclusions and information on the safety and efficacy of the drug, so as to guide safe and rational use of the drug. The detailed format, content and drafting requirements for drug package inserts shall be formulated and issued by the State Food and Drug Administration.

Article 10 In expressing disease names, pharmaceutical technical terms, drug names and clinical test names and results, drug package inserts shall adopt the specialised vocabulary uniformly promulgated or standardised by the State, and units of measurement shall comply with the provisions of national standards.

Article 11 Drug package inserts shall list all active ingredients or all traditional Chinese medicine components in the formula. Injections and over-the-counter drugs shall also list the names of all excipients used.

Where a drug formula contains ingredients or excipients that may cause serious adverse reactions, this shall be explained.

Article 12 Drug manufacturers shall take the initiative to track the safety and efficacy of a drug after it is marketed, and where the drug package insert needs to be modified, shall submit an application in a timely manner.

Based on information such as adverse drug reaction monitoring and the results of drug re-evaluation, the State Food and Drug Administration may also require drug manufacturers to modify the drug package insert.

Article 13 After modification of a drug package insert is approved, the drug manufacturer shall immediately notify the relevant drug distributors, user units and other departments of the modified content, and shall use the modified package insert and labels in a timely manner as required.

Article 14 Drug package inserts shall fully contain information on adverse drug reactions and specify the adverse drug reactions in detail. Where a drug manufacturer fails to modify the package insert in a timely manner according to the safety and efficacy of the drug after marketing, or fails to fully explain the adverse drug reactions in the package insert, the adverse consequences arising therefrom shall be borne by that manufacturer.

Article 15 The date of approval and the date of modification of a drug package insert shall be conspicuously indicated in the package insert.

——This article is reprinted from China Packaging Network (pack.cn), original link: http://news.pack.cn/show-362254.html