Drugs
NMPA issues the Notice on Enabling the New Version of the Drug Production License and other Certificates
Updated: Aug 7, 2019
english.nmpa.gov.cn
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As per the Drug Administration Law of the People's Republic of China, the Regulations for Implementation of the Drug Administration Law of the People's Republic of China and the regulations on postmarketing supervision of pharmaceuticals, NMPA uniformly formulated the formats of Drug Production License and other Certificates. To standardize the formats and renewal of the drug administrative licenses, on August 7, 2019, NMPA issued the Notice on Enabling the New Version of the Drug Production License and other Certificates, and notified the relevant matters as follows:
1. NMPA shall uniformly formulate the formats of new versions of the Drug Production License, Medical Institution Preparation License, Pharmaceutical Preparation Certificate for Medical Institution, Radioactive Drug Production License, Radioactive Drug Distribution License and Radioactive Drug Use License, and Internet Drug Information Service Qualification Certificate(including original and copy). The original and copy of the new certificates must indicate the daily regulatory agency and phone numbers for supervisory report, implement the supervisory responsibility, and accept social supervision.
2. The new version licenses shall be enabled as from September 1, 2019. The drug regulatory authorities of the provinces (autonomous regions and municipalities) shall issue relevant certificates to the new applicants in the new formats.
In areas where electronic certificates are issued and used, the e-Cert style should be consistent with the new version of the paper certificates.
3. The Drug Administration of all provinces (autonomous regions, municipalities) shall attach great importance to the renewal of the new version of the license, with careful deployment taking into account the actual situation, to ensure smooth and orderly replacements. It is necessary to clearly indicate the handling standards, procedures and time limit, and perform strict review. Where requirements are not met, the certificates shall not be renewed.
4. To facilitate unified management, the licenses not to be expired in 2019 shall be replaced by the Drug Administration of all provinces (autonomous regions, municipalities) before the end of December 2020, with validity period self same as the original certificates.
5. Should any problems and suggestions arise therein, please contact the NMPA Department of Drug Supervision in time.
