Europe
The European Medicines Agency (EMA) has recently published several important updates to Good Pharmacovigilance Practices (GVP) guidance:
- GVP Module VI – Addendum II introduces new guidance on the masking of personal data in Individual Case Safety Reports (ICSRs) submitted to EudraVigilance. The addendum clarifies how personal identifiers should be protected while maintaining data integrity for safety evaluation.
- The GVP Introductory Cover Note has been updated to reflect these new provisions and to align references across the revised modules and addenda.
- GVP Module XVI – Addendum I: Risk minimisation measures for medicinal products with embryo-fetal risks. This addendum provides guidance on risk minimization measures (RMMs) aimed at:
– preventing exposure of an embryo/fetus, at conception or in utero, to a medicinal product with an established or potential risk of embryo-fetal toxicity; or
– minimizing embryo-fetal risks if such exposure of an embryo/fetus to such a medicinal product may have occurred.
These revisions aim to enhance data protection, strengthen risk management evaluation, and ensure consistency across pharmacovigilance activities within the EU network.
Sources:
GVP Module VI Addendum II – Masking of personal data in ICSRs for EudraVigilance
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