NMPA (China)
National Medical Products Administration
China's regulatory authority for drugs, medical devices and cosmetics — successor to CFDA, operating under the Drug Administration Law and Medical Device Regulations.
NMPA administers China's drug GMP (2010 edition, with appendices), Medical Device Production Quality Management Standard (essentially ISO 13485-aligned with Chinese specifics), and Cosmetics Supervision and Administration Regulation (CSAR, 2021). China became an ICH regulatory member in 2017 and has progressively adopted ICH guidelines.
Foreign manufacturers require a domestic Marketing Authorisation Holder (MAH) for drugs and a Legal Agent for devices. NMPA on-site inspections (including unannounced) have increased materially since 2020.
- PRC Drug Administration Law (2019 rev)
- Medical Device Regulations (Order 739, 2021)
- NMPA Drug GMP (2010)
Free trial, no credit card, onboard in days, not months.