China Drug Master File(DMF)
Regulations & Standards
Regulations & Standards
China Drug Master File (DMF) for APIs, packaging Materials and pharmaceutical excipients are regulated by China NMPA formerly CFDA. The related DMF regulations and standards clarifies the drug master file structure, process, requirements, timelines and costings in the regulations listed in table below. For questions on the requirements, you may contact us:
| Category | Regulations & Standards | Summary | Link | Download |
|---|---|---|---|---|
General Laws |
Drug Administration Law (2019 No.31) |
Regulatory basis for the development, manufacture, business operation, practical use, supervision and administration of drug products, substances, excipients, and packaging materials. | https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html (Chinese) For English version, please contact us. | |
Provisions for Drug Registration (2020 No.27) |
Regulatory basis for DMF approval pathways in Section 3 of Chapter 3. | https://gkml.samr.gov.cn/nsjg/fgs/202003/t20200330_313670.html (Chinese) For English version, please contact us. | ||
Announcement for Adjusting Evaluation and Approval for APls, Excipients and Packaging Materials (2017 No.146) |
Basic requirements for the binding review and approval of a drug and its related APIs, excipients, and packaging materials. | https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/2017110163301730.html (Chinese) For English version, please contact us. | ||
DMF Standards |
Announcement on Issues Concerning the Further Improvement of Drug-related Associated Review & Approval and Supervision (2019 No.56) |
Detailed requirements for DMF filing, incl. scope of DMF, dossier requirements, filing process and timeline under the framework of binding review and approval. | http://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20190716174501955.html (Chinese) For English version, please contact us. | |
Provisions for Administration of Drug-related Associated Review & Approval for APIs, Excipients. and Packaging Materials (2020 Draft for Comments) |
Comprehensive administrative practices of DMF filing, incl. API independent review & approval, DMF holder responbilities& obligations, changes to approved DMFs and product supervision by the authorities. | http://www.cde.org.cn/news.do?method=largeInfoid=561f13ofad55ba4 (Chinese) For English version, please contact us. |
For English translations or questions on China’s Drug Master File (DMF) requirements, you may message us on: info@accestra.com