China's pharmacovigilance framework is built on the Drug Administration Law and the NMPA Good Pharmacovigilance Practice (GVP), supported by the national adverse-drug-reaction monitoring system.
Core official resources
- Drug Administration Law of the People's Republic of China — establishes the national pharmacovigilance system and the MAH duty to monitor, collect, analyse and control drug risks.
- NMPA Good Pharmacovigilance Practice — the central GVP framework for MAHs and applicants; effective from 1 December 2021.
- Provisions for Adverse Drug Reaction Reporting and Monitoring — detailed rules for ADR reporting, monitoring and follow-up.
Practical use
The NMPA GVP requires MAHs to establish and continuously improve a pharmacovigilance system. The older ADR reporting provisions remain useful for detailed reporting mechanics and timelines, but company procedures should always be checked against the current GVP and any newer NMPA implementation notices.