A Look at the New Rules for Chemical and Biological Drug Filings in China:
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has released the “Guidelines for Acceptance and Review of Chemical Drug Registration (Trial)” and “Guidelines for Acceptance and Review of Biological Product Registration (Trial)”. Both sets of guidelines will take effect from March 10, 2025.
Details of the Guidelines:
The “Guidelines for Acceptance and Review of Chemical Drug Registration (Trial)” are divided into two parts. They are applicable to clinical and market filings for innovative drugs/modified drugs (Categories 1, 2, 5.1) and generic drugs (Categories 3, 4, 5.2). On the other hand, the “Guidelines for Registration and Acceptance Review of Biological Products (Trial)” consist of three parts. These are applicable to clinical and market filings for preventive and therapeutic biological products, as well as market filings for in vitro diagnostic reagents managed under biological product management.
Key Requirements:
Both sets of guidelines specify the basic requirements for relevant drug filing materials. They also outline the key points for formal review and acceptance review decisions. This move by the NMPA aims to further standardize the drug registration process in China, ensuring that the quality and safety of drugs meet the required standards. The new guidelines are expected to have a significant impact on the pharmaceutical industry, guiding drug manufacturers in the preparation and submission of registration materials, and promoting the healthy development of the industry.-Fineline Info & Tech
