International representation
Fimea actively involved in international medicines regulatory networks
Fimea is a central part of the European medicines regulatory network that, in addition to the European Commission and the European Medicines Agency (EMA), also comprises the national competent authorities (NCAs).
The European medicines regulatory network has widely shared procedures and processes in place that are developed in committees and working groups formed of national experts. Fimea is actively involved in them through its own expert members, and in its chosen strategic priority areas, Fimea is also seeking to assume leading and influential chairing duties.
In addition to expertise, assignments received under the common processes of Member State agencies are also shared within the network, which brings work and income to the national medicines agencies. Within the confines of their EU responsibilities, Fimea’s experts attend to the centralised reporting and co-reporting duties pertaining to marketing authorisation applications, conduct inspections on pharmaceutical and active pharmaceutical ingredient plants in the EU area or in the so-called third countries, and contribute to the European quality inspection and European Pharmacopoeia work. Active involvement in the operation and discussions of the European medicines regulatory network is also a basic prerequisite for maintaining the agency’s competence at a high international level so as to also be able to fulfil the needs of the national pharmaceutical industry operators.
The European Medicines Agency (EMA) is one of the largest EU-level agencies. Under the so-called centralised procedure, the EMA coordinates marketing authorisation applications for medicines and variations to them. The EMA also coordinates operator inspections of various kinds and the work of scientific committees. These committees express an opinion on the marketing authorisation applications and draft EU-level regulations and amendments to them. The EMA is also responsible for collecting the adverse reactions to medicines reported in the EU area and for creating and maintaining the supranational computer systems used by all agencies.
The national regulatory agencies also operate in the Heads of Medicinal Agencies (HMA) network between the Member States. The marketing authorisation applications received from marketing authorisation applicants under the decentralised and mutual recognition procedure, among other things, are coordinated within the HMA.
Read more:
Fimea’s international representation (pdf)
European experts (EMA)