I. Regarding Drug GMP Certificates

On December 1, 2019, the newly revised "Drug Administration Law of the People's Republic of China" officially took effect. As of that date, Drug Good Manufacturing Practice (GMP) certification certificates are no longer issued. In accordance with the law, China's drug regulatory authorities conduct inspections of drug manufacturers' compliance with Good Manufacturing Practice (GMP) standards and oversee their continued compliance with statutory requirements.

II. Regarding Certificates for the Export and Sale of Drugs

In November 2018, the National Medical Products Administration (NMPA) issued and implemented the "Regulations on the Administration of Certificates of Pharmaceutical Product Export Sales." According to these regulations, the provincial-level drug regulatory authority where a pharmaceutical manufacturer is located may, upon the company's application and under the World Health Organization's International Trade in Pharmaceuticals Certification Scheme, issue a Certificate of Pharmaceutical Product Export Sales (CoPP) for exported pharmaceuticals or active pharmaceutical ingredients (APIs). This certificate attests to the company's marketing status in China and its history of undergoing GMP inspections by Chinese drug regulatory authorities.

In 2025, the "Regulations on the Inspection of Exported Drugs and the Administration of Export Certificates for Pharmaceutical Manufacturers" were issued (effective January 2026; the original "Regulations on the Administration of Certificates of Pharmaceutical Product for Export" were simultaneously repealed), and the CoPP template was updated in accordance with the latest template recommended by the World Health Organization.

Issued CoPPs are publicly available in both Chinese and English on the website of the National Medical Products Administration (NMPA). On the English website (https://english.nmpa.gov.cn), the path to search for CoPPs is "Home >> Database >> Certificate of a Pharmaceutical Product.”