China Amends DMF System on Drug Packaging

China first established a Drug Master File (DMF)-type system for the registration of drug packaging materials, active pharmaceutical ingredients (APIs), and drug excipients in Announcement No. 146 of 2017, published by the former China Food and Drug Administration (CFDA). Under the registration system, a company first needs to submit to the Center for Drug Evaluation (CDE) the registration dossier for a packaging material, API, or drug excipient and obtain a registration number. The registration dossier will later be reviewed together with the application for the correlated pharmaceutical product.

A significant update to the registration dossier procedures was announced on July 16 and became effective on August 15, when China's National Medical Products Administration (NMPA) issued Announcement No. 56 of 2019, which clarifies and simplifies the procedure and requirements for the registration of drug packaging, APIs, and drug excipients in China.

With respect to drug packaging, the Announcement amends the registration dossier requirements. Notably, data requirements for certain categories may be reduced for drug packaging materials where the data needed for registration are determined according to the risk level and use information about a particular drug packaging material. For example, if a drug packaging material has not been used in pharmaceutical applications but has lawful use in direct contact with food as food packaging materials, there may be a reduction in data requirements.