News16.09.2025

Here’s this week’s global Pharmacovigilance regulatory intel 🌍

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Here’s this week’s global #Pharmacovigilance regulatory intel 🌍

📚 ICH – M14 Guideline: Reaches Step 4 of the ICH process. (New)

🇪🇺 EU – IRIS: Updated FAQ on regulatory procedure management for product lifecycle management in IRIS. (Updated)

🇦🇲 🇧🇾 🇰🇿 🇰🇬 🇷🇺 EAEU – GCP Rules: Amendments to the EAEU Good Clinical Practice Rules. (Updated)

🇦🇺 Australia – GVP Module I: Adoption of EMA/541760/2011. (New)

🇪🇬 Egypt – EDA: PSUR supplementary list refreshed. (Updated)

🇺🇸 USA – FDA: Final Guidance E6(R3) Good Clinical Practice published. (New)

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#DrugSafety #ICH #FDA #EMA