China Starts to Issue Electronic Drug Registration Certificates

by Grace Wang Nov 01, 2022

From Nov. 1, 2022, China National Medical Products Administration (NMPA) will issue drug registration certificates in electronic version, which is as legally valid as the paper version.

Electronic drug registration certificates1 will cover:

Ÿ   Clinical trial approval certificate

Ÿ   Marketing authorization certificate

Ÿ   Re-registration certificate (for registration renewal)

Ÿ   Supplemental application approval certificate

Ÿ   Traditional Chinese medicine (TCM) protection certificate

Ÿ   Imported raw ingredient certificate

Ÿ   Certificate for active pharmaceutical ingredient (API) of chemical drug

Ÿ   Good laboratory practice (GLP) certificate

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.

Documents such as drug manufacturing process document, quality standard document, medication package insert, and label will not be included in electronic drug registration certificate itself. Instead, along with the electronic certificates, the attachments will be available in electronic form on the same online service platform mentioned above.

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.

Grace Wang
ChemLinked Regulatory Analyst
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