Management review 2024

© GettyImages/AleksandarNakic

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. Our more specific strategic priorities are measures related to foresight and preparedness, taking care of the capabilities of the work community and influencing using our expertise. Our goals are to promote wellbeing and safety through our own actions, effective supervision and the production of reliable and value-adding expert information. We also want to be public administration pioneers in the search for new perspectives and innovative operating methods.  

We have continued the systematic development of our operational systems, e-services and registers. The pharmacy register was introduced to production use in early 2024. A system enabling the processing of pharmacy licences and e-services was then designed and implemented and will be integrated and launched in early 2025. The system will facilitate pharmacy permit procedures and reduce manual work. The digitalisation of the special permit process for medicines also continued throughout 2024. The new special permit register and e-services will be introduced in early 2025.  

The business year was one of active cooperation within the European network of pharmacovigilance authorities. Naturally, the main focus was on the reform of EU pharmaceutical legislation. We participate actively in the processing of the EU medicines package by offering our expertise to assist the Ministry of Social Affairs and Health.   

2024 was also the year of implementation of numerous EU regulations. The transitional period for the Clinical Trials Regulation expired on 30 January 2025, before which all studies subject to the Directive had to be transferred under the Regulation. The new EU regulation on the quality and safety requirements for substances of human origin intended for human use (the SoHO regulation) was adopted in June and the implementation will continue until August 2027. In cooperation with the Ministry of Social Affairs and Health and the Finnish Transport and Communications Agency Traficom, preparations were also made for the national implementation of the Cybersecurity Directive (the NIS2 Directive), the Critical Operator Resilience Directive (the CER Directive) and the EU AI Regulation. 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.   

Our cooperation with stakeholders to promote rational pharmacotherapy continued, for example, in the patient advisory board and the medicines information network. The Research Network for Rational Pharmacotherapy (RATTI), coordinated by Fimea, published the Rational Pharmacotherapy and Pharmacotherapy Supply Chain Research Strategy in December 2024. The vision presented in the strategy is that research on rational pharmacotherapy and the pharmacotherapy supply chain will be systematic and respond to the needs of medicine users and the health and social services system.  

In 2024, we continued our premise development projects as part of the productivity programme of the administrative branch of the Ministry of Social Affairs and Health. In addition to the joint work environment development projects of the Tampere and Kuopio offices (YTY), a similar project is under way in Turku and will be completed in 2025. Process development enabled by IT system development will also play a key role in our ongoing productivity programme measures. The BI reporting project supporting knowledge-based management, the reform of tools and methods and the piloting of the utilisation of artificial intelligence, for example, in the automation of routine tasks, analysis of large amounts of data and improvement of information management, are part of this package. 

As work and the operating environment change rapidly, we want to invest in the wellbeing and energy of our personnel. As part of this aspect, we continuously develop our supervisory work and management. The year’s themes in supervisor training were the management of multi-location work and the supervisor’s own energy. In addition, we reformed our work community communications by introducing a new intranet and an internal discussion platform with the aim of improving internal communications, promoting a sense of community and supporting multi-location hybrid work.   

The year 2024 demonstrated that despite the challenges, we have succeeded in our work. 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.  

We would therefore like to thank all stakeholders for their trust and successful cooperation in 2024. We would also like to thank our committed and competent staff for their excellent work.  Only with our strong, impressive expertise will we succeed in our work – and keep medical products safe, accessible and used rationally.