Pharmaceutical Regulations in China
In China, Pharmaceuticals are regulated by The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly known as the China Food and Drug Administration or CFDA).
Table of contents
General Drug Regulations
| Document Number | Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|---|
| Order No.28 | Administrative Measures for Drug Registration | NMPA | The Measures applies to the applications for drug clinical trial, drug production or import, and conducting drug approval, relevant testing for drug registration, or regulation thereof, within the territory of the People's Republic of China. | English | For Sale |
| Order No.04 | Administrative Measures for Drug Importation | NMPA | These Measures shall apply to the registration of importation, customs declaration, port inspection and importation of pharmaceuticals. | English | For Sale |
drug master file registration
| Document Number | Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|---|
| No. 56 of 2019 | Announcement on Further Improving Related Issues Concerning Drug Evaluation, Approval and Supervision (DMF for API, Pharmaceutical Packaging Materials and Excipients)(No. 56 of 2019), July 15, 2019 | NMPA | The Announcement on Adjusting the Review & Approval Items of APIs, Pharmaceutical Excipients and Packaging Materials (Announcement No. 146 of 2017) issued by the former CFDA, on July 16, 2019, | English | For Sale |
| No.146, of 2017 | Announcement on Approval of Active Pharmaceutical Ingredients (API), Pharmaceutical Excipients and Pharmaceutical Packaging Materials for Drug Products No.146, November 30, 2017 | NMPA | The former CFDA issued the Announcement on Adjusting the Review and Approval of Active Pharmaceutical Ingredients, Pharmaceutical Excipients on November 30, 2017. | English | For Sale |
orphan drugs
| Document Number | Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|---|
| - | NMPA: List of the First Batch of Rare Diseases | NMPA | The NMPA has issued its first list of rare diseases at the national level in May 11, 2018 that outlined the rare diseases in China. | English | Complimentary |
GRP Whitepaper: Registration of DMF of Pharmaceutical Packaging materials in china
Since July 2019, NMPA requires manufacturers of Pharmaceutical Packaging Materials (PPM) to register the DMF of their products using CDE platform and obtain a DMF number.
GRP Whitepaper: Registration of DMF of excipients in China
In mid 2019, NMPA implemented a new process for pharmaceutical excipients registration in China, manufacturers have to register the DMF of their excipients using the CDE platform that generates automatically the DMF number.