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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