Pharmacovigilance
11 Jun 2026
New GVP guidance for pregnant and breastfeeding women
The EMA has issued new GVP guidance on medicines used by pregnant and breastfeeding women. Here is what...
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Expert perspectives from the M.P.C.A. International team on Regulatory Affairs, Pharmacovigilance, GMP/GDP and market access in the Benelux.
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ICH E2D(R1): new standards for post-approval safety data
The revised ICH E2D(R1) guideline is now in effect in the EU. Here is what changes for post-approval safety reporting and how to get ready.
Read full article Pharmacovigilance
GDP & Distribution
11 Jun 2026
Stock Monitoring Tool: the 1 July go-live looks set to be postponed
An early heads-up: the FAMHP’s Stock Monitoring Tool, due to go live on 1 July 2026, looks set...
Regulatory Affairs
11 Jun 2026
Article 10 and the RIP role: takeaways from the FAMHP info session
Several MPCA colleagues attended the FAMHP’s info session on Article 10. Here is what the updated guidance means...
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