Fimea’s final accounts and annual report for 2025 have been published

The Finnish Medicines Agency Fimea’s final accounts and annual report for 2025 have been published. “In 2025, Fimea continued with determination to reform its operations and systematically develop its services,” says Eija Pelkonen, Director General of Fimea. 

In 2025, several new registers and e-services streamlining operating methods were introduced, such as an electronic service for pharmacy licences. “According to a customer satisfaction survey conducted in November 2025, Fimea has succeeded in improving its services and enhancing the efficiency of its processes, and our customers considered Fimea reliable and an expert in our field,” Pelkonen says.

A European consensus was reached on new pharmaceutical legislation in December 2025. “The impact of the EU medicines package is nationally significant for both Fimea and our stakeholders,” Pelkonen emphasises. Fimea supported the Ministry of Social Affairs and Health and actively contributed to highlighting national special characteristics and objectives in the preparation of EU legislation. The objectives of the reform include promoting the development of pharmaceuticals, ensuring the availability of medicines, reducing the environmental impacts of medicines and streamlining administrative processes, among other things.

Farmasto is progressing

In 2025, preparations were also made for the construction of the medicines data repository Farmasto, which will compile official information on medicines. The preparations were carried out in cooperation with other authorities by drawing up project and implementation plans. The first information products are due to be published on the farmasto.fi website in autumn 2026. 

As a result of the EU’s new AI Act and Fimea’s expanding supervisory responsibility, Fimea also continued to strengthen its AI expertise, for example, in the area of supervision of medical devices.

“We wanted to ensure our expertise and ability to act at the pace required by the rapidly changing operating environment, so we developed and implemented the Strategic Human Resources Planning model,” Pelkonen explains. “The aim is to gain a common and transparent understanding of expertise and to establish effective and concrete practices for strengthening Fimea’s expertise.”

Fimea is a net budgeted agency that is funded mainly by the customer fees of pharmaceutical operators. In 2025, marketing authorisations for medicinal products, licence and audit fees for pharmaceutical operators and quality control fees under the separate statute accounted for approximately 86% of the agency’s total funding. The remaining 12% was operations funded from the state budget, which include general governmental oversight of pharmaceuticals, pharmacopoeia work and the assessment of pharmacotherapies, and 2% was project funding and other income received from the EU and the Ministry.

Final accounts and annual report 2025 (julkari.fi, in Finnish)