Article 43 of the Clinical Trials Regulation imposes an obligation on sponsors to submit Annual Safety Reports (ASRs) concerning the safety of each Investigational Medicinal Product used in a clinical trial, and a related obligation on the competent authorities of EU Member States to assess these. The EMA has published new Member States Guidance: New Safety Module on the Annual Safety Report and Sponsor Guidance: New Safety Module on the Annual Safety Report to support this process.
The Member States Guidance provides competent authorities with the operational guidance they need to assess ASRs submitted by sponsors through the New Safety Module. The Sponsor Guidance provides clinical trial sponsors with the operational guidance they need to submit ASRs, including responses to relevant Requests for Information.