NMPA Guidelines for Pharmacovigilance Inspection

On 15 April 2022 the Chinese NMPA published the announcement of distributing the PV inspection guidelines (NMPA [2022] No. 17).

These guidelines are applicable to the inspections conducted by the drug regulatory authorities at or above the provincial level on the pharmacovigilance activities carried out by the drug marketing authorization holders themselves or entrusted by the holders; drug registration applicants who have been approved to conduct drug clinical trials should conduct pharmacovigilance inspections. Combined with drug safety characteristics and clinical trial safety information report and risk assessment, start pharmacovigilance inspection during clinical trial or before marketing authorization, and the specific implementation can refer to this guideline.

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