Pharma Packaging Printing Standards Stay Unchanged as China Keeps Order No. 24

According to information from the State Food and Drug Administration (SFDA), the Registration Division and Market Division of the Beijing Municipal Food and Drug Administration, the Beijing Pharmaceutical Packaging Materials Inspection Institute and other relevant bodies, the printing requirements for printed packaging materials, including outer labels and package inserts for medicines, have not changed. They continue to follow the Provisions for the Administration of Drug Package Inserts and Labels, or SFDA Order No. 24, issued on 15 March 2006.

The relevant printing standard policy is as follows:

SFDA Order No. 24, the Provisions for the Administration of Drug Package Inserts and Labels, was reviewed and adopted at the SFDA administrative meeting on 10 March 2006. It was then promulgated and took effect on 1 June 2006.

Article 1 states that the Provisions are formulated under the Drug Administration Law of the People's Republic of China and its Implementing Regulations, with the aim of regulating the administration of drug package inserts and labels.

Article 2 provides that any drug marketed and sold within the territory of the People's Republic of China must have package inserts and labels that meet these requirements.

Article 3 places approval authority for drug package inserts and labels with the SFDA.

Drug labels must be based on the package insert. Their content may not exceed the insert's scope, and they must not carry wording or marks that suggest therapeutic effects, mislead users or improperly promote the product.

Article 4 requires drug packaging to bear printed or affixed labels as stipulated. It may not include any other text, audio-visual or other materials that introduce or promote the product or the company. Small packages made by drug manufacturers for market sale must come with a package insert.

Article 5 requires the wording in package inserts and labels to be scientific, standardised and accurate. Over-the-counter drug inserts must also be easy to understand, so patients can assess, choose and use the medicine on their own.

Article 6 requires clear, legible text and prominent marks in inserts and labels. Print must not flake off, labels must not be poorly adhered, and no changes or additions may be made by pasting, cutting or altering.

Article 7 states that inserts and labels must use standardised Chinese characters issued by the State Language Commission. If another language is added for reference, the Chinese text governs.

Article 8 allows drug manufacturers to propose adding warning statements to inserts or labels for public health protection and rational drug use. The SFDA may also require such warnings.

Chapter II Drug Package Inserts

Article 9 requires inserts to include key scientific data, conclusions and information on drug safety and efficacy to support safe and rational use. The SFDA sets and issues the detailed format, content and drafting requirements.

Article 10 states that inserts must use nationally promulgated or standardised terminology for disease names, pharmaceutical terms, drug names, clinical test names and results, while units of measurement must follow national standards.

Article 11 requires inserts to list all active ingredients or all traditional Chinese medicine ingredients in the formula. Injections and over-the-counter drugs must also list all excipients.

If a formula contains ingredients or excipients that may cause serious adverse reactions, this must be explained.

Article 12 requires drug manufacturers to actively monitor safety and efficacy after a drug reaches the market and to apply promptly when the insert needs revision.

Based on adverse drug reaction monitoring, drug re-evaluation results and other information, the SFDA may also require manufacturers to revise inserts.

Article 13 provides that once an insert revision is approved, the manufacturer must immediately notify relevant drug distributors, user units and other departments, and must start using the revised insert and labels on time as required.

Article 14 requires inserts to fully include adverse drug reaction information with specific details. If a manufacturer fails to revise an insert in time based on post-market safety and efficacy, or fails to fully explain adverse reactions, the manufacturer bears the adverse consequences.

Article 15 requires the approval date and revision date of an insert to be conspicuously shown in the insert.

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