Management review 2023

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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.  

In spring 2023, Fimea published the National Risk Medicines Classification to support and promote medication safety in social welfare and health care. The report on the knowledge management methods of rational pharmacotherapy and pharmaceutical services was completed, and we launched the specification of the objectives of national rational pharmacotherapy and pharmaceutical services. The preparation of the medicines data repository, intended as an umbrella of drug information, continued with the production of an administrative and organisational model and a more detailed solution description.  

Fimea continued the development and digitalisation of its service processes with several projects. A modern data platform was developed to promote knowledge management and information management, and the first connections were made to Fimea’s systems and datasets. The cloud transition, launched in 2022, progressed as planned and in line with the cloud policies for the public sector by transferring existing systems to the cloud and developing new cloud-based solutions.

The updated e-service for reporting adverse reactions to human and veterinary medicines was launched, and the updated adverse drug reaction database was rolled out in December. Fimea’s new shortage register and e-service channel for receiving shortage notifications were completed at the turn of May and June 2023. Fimea’s pharmacy register was updated, and the roll-out of the new register is starting in January 2024. The new pharmacy register generates a versatile and up-to-date pharmacy data repository whose data can also be used by non-authorities. The information in the pharmacy register creates a basis for the pharmacy information in services such as Kanta.

The assessment of pharmacotherapies (HTA) piloted a new, application-based operating model to promote the predictability, coverage and balance of assessment activities. In the supervision of clinical drug trials, all new trials are now subject to EU regulation as of 31 January 2023. 
Implementation of the MD and IVD regulations for medical devices continued in the medical devices sector. Fimea actively invested in the supervision and designation of notified bodies to support the implementation of the new regulations. Fimea designated the first notified body under the IVD Regulation in Finland in September and the second one in October. By the end of 2023, twelve notified bodies have been designated in all of EU under the IVD Regulation, two of which are now in Finland. 

Fimea’s laboratory facility project was completed in autumn 2023. Although there are now fewer square meters of laboratory facilities in total, the new facilities are more functional and geared to meet the national and European quality control requirements of medicines on the market.  
For European cooperation on pharmaceutical regulation, 2023 was a very busy year. In April 2023, the European Commission issued its proposal for the reform of pharmaceutical legislation and for measures against the threat of antibiotic resistance. Extensive substantive reforms of the EU pharmaceutical legislation that entered into force twenty years ago in 2004 have been proposed to meet the needs of the changed operating environment. In addition to the pharmaceutical legislation reform, the Commission proposed further measures to strengthen the fight against antimicrobial resistance. Fimea actively participated in and supported the Ministry of Social Affairs and Health in the preliminary assessment of the impacts of the proposed legislative amendment, and the work is naturally ongoing.

In 2023, a major challenge was resource shortages in different medicines agencies in the EU, and finding assessment teams for new marketing authorisation applications has been increasingly difficult. This capacity issue in the EU is being addressed by improving and increasing cooperation between different pharmaceutical authorities in the EU, by creating new, more effective working methods and by training new assessors. Fimea has been actively involved in finding solutions to these capacity challenges, both in EU working groups and in the Commission’s project.
Compared to its size, Fimea has a fairly large part in the rapporteur or co-rapporteur tasks of centralised marketing authorisations coordinated by the European Medicines Agency (EMA), especially in the assessment of biosimilars, ATMPs and products intended for the treatment of cancer and autoimmune diseases. To support innovation efforts, Fimea also invested in the provision of scientific-regulatory advice prior to the marketing authorisation stage, to offer actors engaged in pharmaceutical development advice in matters related to the planning and implementation of research. A majority of these consultations were related to innovative cancer drug development.

In November, Fimea underwent the Benchmarking of European Medicines Agencies (BEMA V). BEMA assessments aim at consistent and high-quality regulatory operations in all medicines agencies in Europe, the current number of which is about 40. In the assessment, Fimea received the highest score for crisis management focusing on human and animal health, information security and inspection activities. Good practices highlighted by the assessors included the stakeholder and job satisfaction surveys that give us information on the level of our operations and related development targets. The risk assessment process and the medicine stock monitoring tool developed during the COVID-19 pandemic were also considered to be exemplary for the entire network of European medicines agencies.

The year was busy and there was much to do, but we should be proud of our achievements and our contribution to Finnish health care and improved patient care. Special thanks are due to our expert professional staff as well as our cooperative partners!