News archive
382 results
Fimea’s final accounts and annual report for 2025 have been published
Fimea.fi user survey is now open
Nordic pilot of medicine packages in English for small-scale hospital products will continue
Fimea and Tukija to speed up evaluation of national clinical trials
Fimea prepares for the expansion of non-prescription medicine sales channels
Report on joint inspections at EU level published – Fimea participates in strengthening market surveillance in the EU
More detailed instructions for the FAST-EU pilot on clinical drug trials published for sponsors
How does a professional user benefit from ensuring conformity?
Fimea has released a guideline page on using artificial intelligence in medical devices
Manufacturers of medical devices must report serious incidents using a new form starting May 2026
Number of shortages at similar level to previous years
New decree on fees chargeable by the Finnish Medicines Agency entered into force on 1 January 2026
European Commission published new proposal for the Biotech Act
Amendments to the Act on the Secondary Use of Health and Social Data concerning clinical trials and investigations to enter into force on 1 January 2026
The national medicines data repository will be named Farmasto, ushering in a new era of how authorities manage medicines data
EU Council and Parliament reach an agreement on the pharma package
New study examined development needs of the regulatory competence of European medicines agencies
Maintenance break in the publication archive on 9 December 2025
New substances to be classified as narcotics
FAST-EU project accelerates the assessment of multinational clinical trials in Europe
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