Safety Reporting – Annual Safety Reports
This page provides answers to common or important questions about safety reporting in clinical trials on medicinal products for human use, with a focus on Annual Safety Reports (ASRs, Development Safety Update Reports, DSURs). If you do not find here an answer to your question, we kindly ask you to consult other relevant sources before contacting us, in particular EudraLex – Volume 10.
How to submit ASRs?
ASRs exclusively covering clinical trials not falling within the scope of Regulation (EU) No 536/2014 but within the scope of the German Medicinal Products Act (Arzneimittelgesetz) in the version in force on 26 January 2022 (corresponding to Directive 2001/20/EC) shall be submitted via CESP (Common European Submission Platform).
ASRs covering at least one clinical trial falling within the scope of Regulation (EU) No 536/2014 shall be submitted via CTIS (Clinical Trials Information System). In this case, no additional submission via CESP is required.
The notification obligations towards the competent ethics committee according to section 13(6) of the German GCP Ordinance (GCP-Verordnung) remain unaffected, since not all ethics committees that have given a favourable opinion on a clinical trial falling within the scope of the German Medicinal Products Act and the German GCP Ordinance in the versions in force on 26 January 2022 also participate in the procedures according to Regulation (EU) No 536/2014. Therefore, no arrangement can be made that reduces the number of submissions and at the same time fulfils the legal requirements.
Are there additional reporting requirements related to safety reporting under Chapter VII of Regulation (EU) No 536/2014, such as the submission of monthly, quarterly or half-yearly safety reports or SUSAR line listings?
Documents covering shorter than annual reporting periods, such as monthly, quarterly or half-yearly safety reports or monthly, quarterly or half-yearly SUSAR line listings, are not to be submitted unless explicitly requested.
The submission of quarterly safety reports on clinical trials with investigational medicinal products containing thalidomide is no longer required (Hinweise zur Anwendung von Arzneimitteln, die Thalidomid, Lenalidomid oder Pomalidomid enthalten).