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null Fimea has revised its regulation concerning clinical trials

Fimea has revised its regulation concerning clinical trials

9.12.2019

The new Administrative Regulation 8/2019 of the Finnish Medicines Agency Fimea concerning clinical trials will enter into force on 1 January 2020. It will supersede Fimea’s previous regulation 2/2012.

Following the entry into force of the new regulation, all material related to clinical trials shall be submitted to Fimea electronically. Previously, the trial notification had to be submitted as a signed hardcopy document, but from now on, the regulation also allows electronic signature. CESP (Common European Submission Portal) or Fimea’s Secure Mail Service (with FI-CTA@fimea.fi as the recipient) shall be used as the submission channel for electronic material. Fimea’s clinical trials website will be updated to contain more detailed instructions.

Additionally, the following clarifications and additions, among other things, have been made in the revised regulation:

  • The definition of an interventional clinical trial has been updated.
  • The reporting of suspected unexpected serious adverse reactions occurring in Finland has been updated to be consistent with the current practice.
  • Added the submission of trial results not only to Fimea, but also to the EU Register of Clinical Trials.
  • The requirements pertaining to the labelling of investigational medicinal products have been clarified.
  • The instructions concerning the reporting of vaccines and blood- and plasma-derived medicinal product batches used in clinical trials to Fimea have been clarified.

Read more

Fimea’s Administrative Regulation 8 / 2019, unofficial translation (pdf)

Instructions of material on clinical trials as of 1 January 2020 (pdf)

Ask more

  • Pirjo Inki, Head of Section, tel. +358 29 522 3362
  • Juliana Raitis, Legal Advisor, tel. +358 29 522 3656
  • E-mail address format: firstname.lastname@fimea.fi