Serious Unexpected Adverse Reactions in Clinical Trials (SUSARs)
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.
clinicaltrials (a) fimea.fi