NMPA’s Official English Clarification on GMP & CoPP – A Timely Move for Drug Exporters

Overseas regulatory agencies often ask Chinese drug exporters for a GMP certificate – but since the revised Drug Administration Law took effect in December 2019, China no longer issues such certificates. This information gap has long delayed overseas registrations and inflated compliance costs.

On 31 July 2026, the NMPA published an official English notice –Explanatory Notes on GMP Certificates and Certificates of a Pharmaceutical Product – that clearly addresses two key issues:

• GMP “certificates” are no longer granted; instead, drug authorities conduct dynamic GMP compliance inspections.
• Certificates of a Pharmaceutical Product (CoPP) are issued by provincial regulators following the latest WHO template, and are publicly searchable in both Chinese and English on the NMPA website (english.nmpa.gov.cn).

With China’s APIs, generics, and even some innovative drugs now exported to over 100 countries, this official English guidance directly tackles a critical pain point. It provides a unified, authoritative reference that eliminates fragmented interpretations and lowers institutional barriers in cross-border regulatory communication.

For exporters, this is not just policy news – it is a practical tool. I strongly recommend citing this official note directly in overseas filing processes to clear regulatory doubts and shorten approval cycles.

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