Here’s this week’s global #Pharmacovigilance regulatory intel - ready to share with your team. 🌍
🇪🇺 EMA - IRIS Access for PSURs: New guidance on restoring PSUR access in IRIS, request access via the EMA portal and coordinate with your MAH Industry Coordinator to be re-assigned.
🇪🇺 EMA – PSUR Annex IV: Updated QRD PSUR Annex IV template released for centrally authorised products.
🇳🇱 Netherlands – MEB45 aRMM Update: MEB’s updated Policy MEB45 includes digital formats (videos), QR codes, broader outreach to trainees, and refreshed templates.
🇸🇦 Saudi Arabia – GVP v4.0: SFDA’s new GVP version updates responsibilities, risk management plans, reporting requirements, and adds a new annex for risk minimisation.
🇺🇸 USA – Daily FAERS Data: FDA now publishes daily FAERS adverse event data to speed up safety signal detection.
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#DrugSafety #RegulatoryUpdates #FDA #EMA
