Here's what's new on the #Pharmacovigilance regulatory front...
📖 MedDRA: Version 28.1 published; transition from 28.0 starts Nov 3, 2025.
🇪🇺 EU: GVP Module XVI Addendum I: New guidance on embryo-fetal risk minimization is now effective for new MAAs, RMMs, and studies.
🇪🇹 Ethiopia: Clinical Trials: EFDA updates guidelines on GCP, bioequivalence, authorization, and inspections to align with global standards.
🇯🇵 Japan: Adverse Reaction Reporting: MHLW revises reporting rules with new optional formats and clarified timelines.
🇷🇼 Rwanda: Clinical Trial Guidelines: Draft guidelines open for stakeholder consultation to harmonize with ICH and WHO standards.
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#DrugSafety #RegulatoryUpdates #MedDRA #EMA
