Small country, big agency

© GettyImages/Dmytro Varavin

By population, Finland is only the 17th largest country in the EU. However, Fimea aims to be an influential pharmaceutical regulatory authority also on the international level. As a national authority, Fimea is part of the European medicines regulatory network, and it has succeeded to become a key player in pharmaceutical regulatory affairs at the EU level.

Important role in marketing authorisation and risk management

In 20220, Fimea had an important role as a responsible assessing country in the common marketing authorisation procedures of the national agencies. Finland served as a reference Member State for 67 new marketing authorisation applications. The number of assessments carried out by Fimea as the responsible rapporteur or co-rapporteur country in the centralised authorisation procedure coordinated by EMA has also reached a permanently high level.   

“Our expertise in, for example, biosimilar products, ATMP products and products intended for the treatment of cancer and autoimmune diseases has improved, and this has been noted in the tasks assigned to us”, says Anna Siira, Director, Marketing Authorisations at Fimea.  

The Pharmacovigilance Risk Assessment Committee (PRAC) responsible for risk management and post-market surveillance of medicinal products assigned Fimea 6 new rapporteurships.

Active contribution in EMA and the EU

Fimea continued active contribution through its committee memberships. In addition to committees, Fimea has had an active representation in EMAs working groups. In 2022, EMA carried out a major working group reform: the size of working groups was reduced, and only the best experts in the EU were selected as members.

“Fimea wanted to strengthen its role as an influential national authority and applied for memberships in several working groups in line with its strategy”, says Siira.

Fimea is represented in the following new working groups: Haematology, Methodology, Non-clinical and Oncology, and serves as the vice-chair of the latter. Fimea is also represented in several previously assigned working groups. 

“Fimea is especially known for its expertise in biosimilar products in the bodies and guideline producing working groups of EMA and the World Health Organisation (WHO).

Fimea is the Vice-chair of the EMA Biosimilar Working Party and the Chair the Heads of Medicines Agencies (HMA) Biosimilar Working Group which focuses on issues outside EMAs mandate, such as interchangeability.