Fimea’s final accounts and annual report for 2023 have been published

The Finnish Medicines Agency Fimea’s final accounts and annual report for 2023 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.

For Fimea, 2023 was a year of intense development of operations and systems. “We launched new e-services and continued our active work in producing drug information and promoting rational pharmacotherapy. We continued to develop and digitalise our service processes with several projects,” says Eija Pelkonen, Director General.

“We introduced new adverse event, availability problem and pharmacy registers. We also opened a revamped e-service for reporting adverse reactions to human and veterinary medicines and for receiving reports of availability problems,” says Pelkonen. “In spring 2023, Fimea published the National Risk Medicines Classification to support and promote medication safety in social welfare and health care. In addition, we continued the preparation of the medicines data repository by producing an administrative and organisational model and a more detailed solution description.”  

Fimea continued the implementation of the MD and IVD regulations for medical devices in the medical devices sector. Fimea designated the first notified body under the IVD Regulation in Finland in September and the second one in October. “The location of notified bodies in Finland is an advantage for the diagnostics industry,” says Pelkonen. “By the end of 2023, twelve notified bodies had been designated in all of EU under the IVD Regulation, two of which are now in Finland.”

2023 was also a busy year for European pharmacovigilance cooperation, in which Fimea is actively involved. Extensive substantive reforms of EU pharmaceutical legislation are on the way to meet the needs of a changed environment, and further measures are being taken to fight antimicrobial resistance more effectively. “These changes will continue to occupy Fimea in the coming years,” says Pelkonen.

Fimea's finances rely on cost-effective operations

Fimea is a net budgeted agency that is funded mainly by the customer fees of pharmaceutical operators. In 2023, marketing authorisations for medicinal products, licence and audit fees for pharmaceutical operators and quality control fees under the separate statute accounted for approximately 87% of the agency's total funding. Ten percent was operations funded from the state budget, which include general governmental oversight of pharmaceuticals, pharmacopoeia work and the assessment of medicinal treatment, and 3% was project funding received from the EU and the Ministry. 

Read more:

•    Final accounts and annual report 2023 (pdf, in finnish)  
•    Annual Report website