NMPA Issued the Announcement on GMP

2022-04-04490

III. Requirements for drug GMP and GSP administration 


As from December 1, 2019, drug GMP and GSP certifications shall be cancelled, and the corresponding applications / certificates shall be no longer accepted / issued. Certification applications accepted before December 1, 2019 shall be processed in accordance with the relevant provisions of the original drug GMP and GSP certification. To applications with on-site inspection completed and conformance to requirements before December 1, 2019, drug GMP and GSP certificates can be issued. On-site inspection shall be carried out even after December 1, 2019, where the current regulations require it, and the corresponding results shall be notified to the enterprise; non-compliance found in the inspections shall be dealt with in accordance with regulations pursuant to the Law.


IV. Associated review & approval for chemical APIs 


tarting from December 1, 2019, no drug registration certificate will be issued for chemical APIs, whose manufacturers shall register on the AEP (APIs, pharmaceutical excipients, packaging materials and containers in direct contact with pharmaceuticals) registration platform for associated review & approval.

http://subsites.chinadaily.com.cn/nmpa/2019-11/29/c_456284.htm