The Finnish Medicines Agency (Fimea; Swedish: Säkerhets- och utvecklingscentret för läkemedelsområdet)[2] is a central agency under the Ministry of Social Affairs and Health that regulates medicines, medical devices, blood and tissue products, biobanks, and develops the pharmaceutical industry.

[5] Fimea's tasks and objectives are based on national and EU legislation, government programs, the strategy of the Ministry of Social Affairs and Health, and performance and resource management.

[3] Fimea is part of the European medicines regulatory network and is oriented towards international cooperation.

[3][7][8][9] Fimea acts as the licensing and supervisory authority for human or veterinary medicines, blood and tissue products, and pharmaceutical operators.

[10] Fimea's organizational structure was reformed in 2022 and consists of three functional areas: Marketing Authorizations, Supervision and Availability, and Safety and Effectiveness.