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Pharmacovigilance

Pharmacovigilance and drug-safety obligations for marketing authorisation holders, from MPCA's regulatory watch.

MPCA International - New GVP guidance for pregnant and breastfeeding women 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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MPCA International - ICH E2D(R1) post-approval safety data Pharmacovigilance
11 jun 2026

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...

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