As a marketing authorisation holder you have a statutory obligation to report adverse events to the competent authorities. Sponsors of clinical studies of medicines and bodies carrying out the trials are also required to follow specific instructions for the submission of reports.
Specific rules for the submission, assessment and conduct of clinical trials with medicinal products are set out in the EU Clinical Trial Regulation 536/2014 (CTR). The CTR applies in the European Union as of 31 January 2022.
The Regulation applies to all clinical trials (national and multinational) conducted in the European Economic Area (EEA).
SUSAR reporting under the Clinical Trial Regulation (CTR)
For studies applicable to the CTR, all SUSARs (Suspected Unexpected Serious Adverse reactions) must be reported in the EudraVigilance database and annual safety reports must be submitted in CTIS (Clinical Trials Information System). The sponsor needs to register with EudraVigilance for electronic reporting.
For questions related to the CTR and the reporting of SUSAR’s you should contact the Central Committee on Research Involving Human Subjects (CCMO).
The MEB is not the competent authority in the scope of clinical drug research.