China's NMPA Regulations
China’s Health Authority previously known as the China State Food and Drug Administration (CFDA) was renamed in 2018 to National Medical Products Administration (NMPA) . The NMPA is the government’s administrative body responsible for regulating pharmaceuticals, medical devices, and cosmetics in China.
Inspections
| Document Number | Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|---|
| Decree No. 101 | Regulations for The Administration of Overseas Inspection of Pharmaceutical & Medical Devices | NMPA | This Regulations applies to the inspections of overseas processes in relation to the development and manufacturing of pharmaceuticals and medical devices that have been or are intended to be marketed within the territory of the People's Republic of China. | English | For Sale |
communication with HA
| Document Number | Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|---|
| , Order No.48,2020 | Administrative Measures for the Communication with CDE During Drug R&D and Technical Evaluation | NMPA | These measures regulate the communication between the applicant and the Drug Evaluation Center of the State Drug Administration of China. | English | For Sale |