Chinese GMP clarification
- No new Chinese GMP applications accepted nor certificates issued since 1st of December 2019
- Current GMP certificates already issued before this new policy continue to be valid but will not be renewed after expiration date
- Although Chinese GMP certification has been cancelled, the On-site inspections to manufacturers are still conducted by NMPA whenever required. The authority will issue an approval letter based on the good result after the inspection (similar to EIR report issued by US FDA).
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 1st of December 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 1st of December 2019 drug GMP and GSP certificates can be issued. On-site inspection shall be carried out even after 1st of December 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."
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