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EMA’s New CTIS Safety Module for Annual Safety Reports: Sponsor and Member State Guidance
The European Medicines Agency (EMA) has published two complementary guidance documents explaining the new CTIS Safety Module for Annual Safety Reports (ASRs). Together, they describe the end-to-end process for ASR submission, assessment, safety issue management and finalisation. Sponsor Guidance: New Safety Module on the Annual Safety Report The Sponsor Guidance explains how sponsors will prepare, submit and manage Annual Safety Reports through the new Safety Module. Transiti
Sharan Murugan
15 hours ago3 min read