China

Pharmacovigilance activities in China are regulated by the National Medical Products Administration (NMPA) under the Drug Administration Law and the Good Pharmacovigilance Practice (GVP), effective 1 December 2021. Drug MAHs and registration applicants must establish and continuously improve a pharmacovigilance system and quality-management framework, appoint a pharmacovigilance responsible person, collect and report suspected adverse reactions through the national monitoring system, perform signal detection and benefit-risk evaluation, submit required periodic safety update reports, implement post-marketing risk-management measures and remain subject to pharmacovigilance inspection. The Chinese GVP framework also requires MAHs to establish and maintain a Pharmacovigilance System Master File; official national guidance issued in February 2022 provides instructions for its creation and maintenance. This is a Chinese national master-file requirement governed by Chinese GVP and national guidance rather than the EU PSMF framework. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.