China’s NMPA Announces they will start on Issuance of Drug Electronic Registration Certificates starting November 1st, 2022. China’s National Medical Products Administration (NMPA) will issue drug registration certificates in electronic version, which is as legally valid as the paper version.
For the issue of drug registration certificates in electronic version Marketing authorization holders (MAH) and drug applicants should sign up at NMPA’s online service platform and confirm their real names, then check and download the electronic drug registration certificates. They can also log in to NMPA’s mobile app “中国药监” to check the electronic certificates.
Paper Version & Electronic Version
Compared to the paper version, which will still be in use, the electronic version of drug registration certificates can be faster accessed by the MAHs and drug applicants. Electronic files are also more convenient for MAHs and drug applicants to check the certificates by scanning codes, verify the certificates online, and authorize other parties to use the certificates.
Electronic drug registration certificates will cover:
- Clinical trial approval certificate
- Marketing authorization certificate
- Re-registration certificate (for registration renewal)
- Supplemental application approval certificate
- Traditional Chinese medicine (TCM) protection certificate
- Imported raw ingredient certificate
- Certificate for active pharmaceutical ingredient (API) of chemical drug
- Good laboratory practice (GLP) certificate
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Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.