Pharmacovigilance

Holders of Certificates of Registration and Clinical Research Organisations must update their safety databases and reporting workflows to comply with the new electronic reporting requirements for AEs and SAEs.

Marketing authorization holders must transition to the updated PLM Portal eAF by the mandatory deadline of September 1, 2026, ensuring correct submission of variations, particularly those related to pharmacovigilance.

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.

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