Finland – Finland Prepares for 2020 Introduction of new Clinical Trial Regulations

The Finnish Medicines Agency (Fimea) has outlined the changes to the regulation of clinical trials that will come into force next month. Fimea will move to electronic submissions of clinical trial materials and revise its process for reporting unexpected serious adverse events as part of the changes.

In replacing regulations that date back to 2012, Fimea is bringing its rules and processes up to date with modern practices. The most visible sign of the modernization of the regulations is the adoption of electronic formats for the submission of clinical trial materials. Once the regulations come into force on 1 January, Fimea will receive materials via the Common European Submission Portal and its secure mail service, ending the need for study sponsors to submit a signed hardcopy document…