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Safety reporting

Safety reporting and ICSR management in the post-approval phase, from MPCA's regulatory watch.

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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