Measures for the Administration of Drug Registration was issued by China’s State Administration for Market Regulation (SAMR) on March 1, 2020, and came into effect on July 1, 2020. In order to meet the requirements of the Drug Administration Law and Vaccine Administration Law, the measures aim to reform the drug review and approval system. This post is a reminder to drug manufacturers about key registration requirements for their China registration projects.
Measures for the Administration of Drug Registration in China – Highlights
A summary of the key points of the Measures for Administration of drug Registration has been prepared by Cisema’s experts below.
- Drug registration means that an applicant for drug registration submits applications for drug clinical trials, drug marketing authorization, drug renewal, and supplementary applications in accordance with legal procedures and relevant requirements. Based on laws and regulations and existing scientific knowledge, the drug supervision and administration department will review the safety, effectiveness and quality controllability of the drug, and decide whether to approve the application.
- Drugs are divided into TCM (Traditional Chinese Medicine), chemical drug, and biological product for classified management. NMPA has successively issued registration classification and application dossier requirements for biological products, chemical drugs, and traditional Chinese medicines. For details, please refer to No. 43-2020, No. 44-2020, and No.68-2020.
- Before applying for drug marketing registration, applicants shall complete relevant research work such as pharmacy, pharmacology and toxicology, and drug clinical trials. Drug non-clinical safety evaluation studies should be conducted in a facility accredited by Good Laboratory Practice(GLP) and in compliance with the requirements of the GLP. Drug clinical trials shall be approved, and bioequivalence trials shall be filed. Drug clinical trials should be conducted in drug clinical trial institutions that comply with relevant regulations and comply with the requirements of GCP.
- NMPA establishes a drug registration system for accelerated marketing to support clinical value-oriented drug innovation. For qualified drug registration applications, applicants can apply for breakthrough therapy drugs, conditional approval, priority review approval and special approval procedures. For details, please refer to No. 82-2020.
- NMPA establishes an associated review and approval system for chemical raw materials, excipients, and packaging materials and containers in direct contact with drugs. During the technical review of the drug, the chemical raw materials, related excipients, packaging materials and containers that directly contact the drug are reviewed together.
- Implement classified registration and conversion management for prescription drugs and OTC. The Center for Drug Evaluation (CDE) is responsible for formulating technical guidelines and procedures related to the marketing registration of OTC drugs. The CDE is responsible for formulating technical requirements and procedures related to post-market conversion of prescription and non-prescription drugs. It has not been officially released yet, and is still in the draft stage.
- Applicants may communicate with professional and technical institutions such as the CDE on major issues before applying for drug clinical trials, during the process of drug clinical trials, and before applying for drug marketing authorization. For details, please refer to CDE’s No. 48 of 2020.
By Yu and Jacky. If you would like to learn more about Measures for the Administration of Drug Registration or our registration and CRO services for pharmaceuticals, medical devices, IVDs, cosmetics, health foods, industrial or consumer goods contact Cisema.