Authority Inspection & Compliance Framework
GVP Inspection Readiness
Understanding China's NMPA Pharmacovigilance Inspection Structure (Guideline for Drug Pharmacovigilance Inspection - NMPA No. 2022/17)
Inspection Institutions
Regulatory Authorities
National Level (NMPA)
National Medical Products Administration - Sets inspection standards and assigns inspectors to Drug Inspection Institutions
Provincial Level
Provincial Medical Products Administration oversees regional compliance and coordinates with municipalities
Municipal & County Level
Local authorities manage grassroots compliance and apply inspection standards from higher authorities
Drug Evaluation & ADR Monitoring
Institutes for Drug Evaluation, Reevaluation, and Adverse Drug Reaction monitoring
Drug Inspection Institutions
Local authorities manage grassroots compliance and apply inspection standards from higher authorities
Institutes for Drug Control
Provides expertise in pharmacovigilance standards and safety monitoring protocols
PV Audit Coverage Areas
PV System & PSMF
Pharmacovigilance System Master File compliance and documentation
Safety Monitoring
Ongoing safety surveillance and periodic safety updates (PSUR)
Regulatory Compliance
Alignment with GVP and GCP standards in China's regulatory environment
Individual Case Safety Report collection, evaluation, and reporting procedures
ICSR Management
Qualified inspectors and inspection team designation and conduct
Inspecting Personnel
Unlawful Case Handling
Procedures for managing non-compliant cases and regulatory affairs coordination
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