Clinical drug trials to be processed electronically
In future, Fimea’s annual safety reports on clinical drug trials will be submitted electronically. Starting from 18 November 2019, sponsors will be able to submit the annual safety reports (including DSURs) for clinical drug trials underway in Finland to Fimea electronically. The CESP (Common European Submission Portal) will be used for this purpose.
The CESP is a portal maintained by the Heads of Medicines Agencies (HMA) intended for the encrypted submission of materials to authorities. You must first register before gaining access to the portal. The parties maintaining the portal provide well-organised training on the use of the portal.
For the submission of the annual safety report, the applicant is requested to always choose Regulatory Activity Type” ”Clinical Trial” for the CESP submission, so that it is sent to the clinical trials unit at Fimea. The sender is requested to add EudraCT number and briefly describe (in the form of a heading) which material is in question. Materials must be zipped, and file names may not include non-ASCII characters such as Scandic characters å, ä, ö.
- clinicaltrials @ fimea.fi