EMA publishes updated guidance on good pharmacovigilance practices

9th September 2026

Summary: The EMA has published an updated introductory document for good pharmacovigilance practices (GVP), incorporating the revised Module III on pharmacovigilance inspections. The agency has also outlined planned revisions to GVP modules to reflect amendments to EU pharmacovigilance legislation and recently adopted ICH guidelines, including E2D(R1) and M14. Until the relevant GVP modules are revised, organisations are advised to apply the applicable ICH guidance alongside existing European requirements. The developments are particularly relevant to pharmacovigilance quality systems, inspection readiness and regulatory compliance.

Link: https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/good-pharmacovigilance-practices-gvp

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