Fimea active in EU-level development work
In 2022, Fimea actively contributed to updating the general EU medicines legislation at the European Medicines Agency (EMA). For example, Fimea proposed new regulatory tools to optimise the current processes. In addition, Fimea’s representatives participated in several development projects related to EMA’s functions, such as promoting the use of real world data.
Towards harmonised approaches and guidelines
Fimea has contributed to the creation and further development of the so-called CHMP Learnings concept which aims to improve the consistency of authority actions. In this concept, experience gained in previous processes, prepared policies and made decisions is systematically gathered in a format that supports decision-making in similar future processes. Fimea has also assumed an active role in the preparation of certain EMA scientific guidelines.
Fimea has also had an active input in the European Medicines Agencies Group that processes regulatory issues regarding the mutual recognition procedure and decentralised procedure of human medicines. In 2022, items introduced on the agenda by Fimea included delays caused by the Covid-19 pandemic and processing of renewal applications in the Member States.
CMDv updated its guidelines and prepared new guidelines for the processes introduced by the new Veterinary Medicinal Products Regulation. The aim is to reduce the administrative burden, and we have managed to reduce a significant share of the national special requirements related to the marketing authorisation processes.
Fimea has participated in key groups preparing the implementation of the new EU Health Technology Assessment (HTA) Regulation promoting harmonisation of operations. The Regulation is expected to be in effect in 2025. The end of 2022 saw the launch of more extensive development of the assessment procedure in cooperation with stakeholder groups.
Fimea has proactively coordinated innovation activities between the Member States. The purpose is to bring together topical information about the development of different areas, such as marketing authorisations, safety, clinical trials and HTA activities. The goal is to prepare a functional model to support innovation in the EU and facilitate quick development and market access of innovations. To this end, innovation activities make it easier for different operators to gain access to a consolidated view and reduce duplication of work. Key themes include early advice concerning new ideas, mutual use of expertise on medicinal products, medical devices and transplants of human origin, and possible harmonisation of processes.
Officials in the Medical Devices Unit participated in several working groups at the EU level that prepared the implementation of the MDR and IVDR and guidelines for the operators on practices related to supervision and inspections and the compliance of new technologies, for example. Solutions for the critical shortage of rare devices were sought in cooperation.
In addition, Fimea’s experts have actively contributed to the preparation of the so-called SOHO Regulation, and this work will continue in 2023.
Work continues to reduce supply problems
In 2022, Fimea actively participated in the networks of European national medicines authorities that manage the availability of medicines. The extension of EMA's mandate also strengthened the role of medicines authorities and developed availability management in the EU cooperation network. EMA’s working group of designated national contact points for shortages became operational.
In 2022, Fimea's reporting tasks to EMA concerned the Covid-19 pandemic, the impacts of the aggression to Ukraine on the availability of medicines and drugs for the treatment of monkeypox. Fimea also investigated the availability of antiepileptics and antimicrobials. The most significant national shortages (e.g. supply issues with clonazepam) were also presented for discussion in the EU cooperation network. Fimea’s determined work to reduce disruptions in the availability of medicines continued in a working group that implements the common strategy of EU authorities.
In 2022, planning of the Coordination and Harmonisation of the Existing Systems against Shortages of Medicines – European Network (CHESSMEN) created a burden of work for Fimea. In December, the European Commission approved the financing for the project for a total of 36 months starting from January 2023. Fimea leads one subproject of the EU cooperative project. The aim of the subproject is to prevent and reduce disruptions in availability and prevent their impact on patients.
The project is closely intertwined with the strategy work of the EU medicines authorities concerning the availability management of medicines and the operation and goals of the working group for national contact points. The aim is to harmonise availability management of medicines among medicines authorities to minimise the impact of availability disruptions on patient treatment at a national level.
Fimea laboratory is an attractive partner
The Fimea laboratory actively participated in European quality control programmes concerning, for example, the testing of authorised biological medicinal products and the market surveillance programme for olanzapine. With regard to the testing of biological medicinal products, the Finnish laboratory is an attractive partner, especially because of its competence in cell-culture based quality control.
In addition, Fimea provided scientific advice in the first testing programme for biosimilar products whose results became available in 2022. The Fimea laboratory continued active international collaboration with foreign medicines authorities. In 2022, the Fimea laboratory conducted microbiological quality testing for the medicines authorities of Ireland and Lithuania.