Fimea’s final accounts and annual report for 2024 have been published

The Finnish Medicines Agency Fimea’s final accounts and annual report for 2024 have been published. Articles covering the year’s events as well as statistics and graphs have been compiled on a separate website at: vuosikertomus.fimea.fi

“In 2024, we updated our strategy to better seize the opportunities of a rapidly changing operating environment and to anticipate and prepare for future challenges,” says Eija Pelkonen, Director General of Fimea. “Our strategic priorities are measures related to foresight and preparedness, taking care of the capabilities of the work community and influencing using expertise. Our goals are to promote wellbeing and safety, effective supervision and the production of reliable and value-adding expert information.”

In 2024, Fimea continued to develop its operating systems, e-services and registers. “We introduced a new pharmacy register, and a system that allows applying for pharmacy licences through e-services will soon be launched. The digitalisation of the special permit process for medicines also continued and was introduced in early 2025,” explains Pelkonen.

New EU regulations kept us busy

2024 was also the year of implementation of numerous EU regulations. Fimea was busy with, for example, the national implementation of the Clinical Trials Regulation, the Regulation on standards of quality and safety for substances of human origin intended for human application (“SoHO Regulation”), the Cybersecurity Directive (“NIS2 Directive”), the Critical Entities Resilience Directive (“CER Directive”) and the EU AI Regulation (“AI Act”) and preparing for new supervisory tasks. Operators and stakeholders were instructed and informed on the new legislative requirements, for example at discussion events, several of which were organised during the year.  

In the European medicines regulatory network, the main focus was on the reform of EU pharmaceutical legislation. Fimea participated actively in the processing of the EU medicines package in cooperation with the Ministry of Social Affairs and Health. 

Reputation has improved in the eyes of citizens

According to the T-media Reputation and Trust survey conducted at the end of the year, Fimea’s overall reputation among citizens is at a good level. The reputation had improved in all measured areas, and stakeholders trust Fimea and want to hear its views. Our personnel’s job satisfaction has also improved. 

Fimea is a net budgeted agency that is funded mainly by the customer fees of pharmaceutical operators. In 2024, marketing authorisations for medicinal products, licence and audit fees for pharmaceutical operators and quality control fees under the separate statute accounted for approximately 85% of the agency’s total funding. Thirteen percent was operations funded from the state budget, which include general governmental oversight of pharmaceuticals, pharmacopoeia work and the assessment of medicinal treatment, and 2% was project funding received from the EU and the Ministry. 

Final accounts and annual report 2024 (in Finnish)
vuosikertomus.fimea.fi