lääkevalvontaviranomainen

Lääkevalvontaviranomainen is a Finnish term that translates to "medicines supervisory authority" or "drug regulatory authority" in English. It refers to the governmental body responsible for overseeing the safety, quality, and efficacy of medicinal products in Finland. This authority plays a crucial role in protecting public health by ensuring that only safe and effective medicines are available to the public.

The primary functions of a lääkevalvontaviranomainen include evaluating and approving new medicines before they can be marketed, as well as monitoring the safety of medicines already in use. This involves collecting and analyzing data on adverse drug reactions, inspecting manufacturing facilities, and ensuring compliance with national and international regulations. The authority also provides information to healthcare professionals and the public about medicines. In Finland, the lääkevalvontaviranomainen is Fimea, the Finnish Medicines Agency. Fimea operates under the Ministry of Social Affairs and Health and collaborates with European Union agencies like the European Medicines Agency (EMA) to ensure a harmonized approach to medicine regulation across member states. Its work is essential for maintaining confidence in the pharmaceutical market and safeguarding the health of the population.