Tag archive

Pharmacovigilance

publicEuropean Medicines Agency · European Union · Updated Jul 13, 2026

Post-authorisation safety studies (PASS): Update on Assessment Timelines and Submission Requirements

MAHs must ensure draft protocols are placed correctly in the CTD and that submission planning considers the clarified assessment timelines, with RMP updates contingent upon PRAC endorsement.

Country ComplianceRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Q&A

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publicEuropean Medicines Agency · European Union · Updated Jun 29, 2026

Regulatory Changes in Pharmacovigilance Data Management Following EMA's ISG Meeting

Urgency: High

MAHs must align their workflows to accommodate the updated requirements for signal management and ICSR submissions as per the discussions in the ISG meeting.

Signal ManagementICSRRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: Consultation / Forum

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