Changes to the adverse drug reaction reporting in clinical trials and to the submission procedure for spontaneous reports
The European Medicines Agency EMA will update its EudraVigilance system in November 2017 and Fimea will also deploy a new IT system for adverse drug reaction reports, which will cause an exception in the submission of SUSAR reports (SUSAR = suspected unexpected serious adverse reaction) related to clinical drug trials.
By way of exception, effective from 8 November 2017, the electronically reporting sponsor members of the EudraVigilance network are not expected to submit SUSAR reports to Fimea. However, the sponsors must ensure that any SUSARs occurring in Finland are submitted electronically to the EudraVigilance Clinical Trials module as instructed by EMA.
The sponsors must, without delay, submit to the investigators and Fimea any new significant observations on the safety of an investigational medicinal product according to Fimea’s regulation 2/2012 Clinical Trials on Medicinal Products.
This change in the reporting procedure will remain in force until further notice. Fimea will announce in advance on its website the date as of which the sponsors are expected to submit reports nationally to Fimea again. Any non-commercial sponsors who are not members of the EudraVigilance network and who do not report electronically, should continue to submit written reports directly to Fimea as before.
Submitting spontaneous reports
For spontaneous reports, the procedure to follow is the one described in EudraVigilance Go-Live plan. Between 8 and 21 November, Fimea will no longer accept adverse reaction reports from marketing authorisation holders, and will not send such reports to the marketing authorisation holders or submit them to the EudraVigilance database. From 22 November onwards, the submission of adverse reaction reports will follow a simplified procedure. In this procedure, Fimea will submit adverse reaction reports only to the EudraVigilance database, and will no longer send the adverse reaction reports to the marketing authorisation holders. The marketing authorisation holders will submit adverse reaction reports only to the EudraVigilance database.
Ytterligare information ges av
- Questions related to clinical trial SUSAR reporting: email@example.com
- Questions related to spontaneous reports: FIMEA.EV@fimea.fi