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). The MEB is not the competent authority in the scope of clinical drug research.
A transition period applies from the moment the CTR has entered into force, i.e. starting from 31 January 2022.
In the first year (until 31 January 2023), the sponsor could choose to either submit and have the study assessed according to Directive 2001/20/EC (Clinical Trial Directive), or according to the CTR via CITIS (Clinical Trials Information System).
From 31 January 2023 onwards, all initial applications must be submitted according to the rules of the CTR.
More information about the transition period.
SUSAR reporting under the Clinical Trial Regulation (CTR)
For studies applicable to the CTR, all SUSARs must be reported in the EudraVigilance database and annual safety reports must be submitted in CTIS. The sponsor needs to register with EudraVigilance for electronic reporting. If a sponsor does not have the means to report SUSARs in EudraVigilance, the CCMO should be contacted.
More information about SUSAR reporting in EudraVigilance.
SUSAR reporting under Directive 2001/20/EC (Clinical Trial Directive)
For studies that have been submitted under the Clinical Trial Directive (up to 31 January 2023), all SUSARs also must be reported via EudraVigilance. For investigator-initiated research, there is however still the option to report SUSARs via the SUSAR module of ToetsingOnline. When submitting a SUSAR in ToetsingOnline, it must be indicated whether the SUSAR has already been sent to the EudraVigilance database.
During the transition period, studies that were originally submitted under the requirements of the Clinical Trial Directive can be converted to the CTR, please see: Questions and answers CTR
After the 3-year transition period (end of January 2025), all ongoing clinical trials must meet the requirements of the CTR.