lääkevalvonnan

Lääkevalvonnan, or pharmaceutical supervision, refers to the system and activities involved in ensuring the safety, efficacy, and quality of medicinal products. In Finland, this responsibility is primarily held by the Finnish Medicines Agency, Fimea. Lääkevalvonta encompasses a broad range of functions, from the initial authorization of medicines to their ongoing monitoring after they have entered the market.

The process begins with the assessment of applications for marketing authorization. Fimea rigorously reviews scientific data submitted by pharmaceutical companies to determine if a new drug is safe and effective for its intended use. This involves evaluating preclinical studies, clinical trials, and manufacturing processes. Once a medicine is approved, lääkevalvonta continues through post-marketing surveillance. This includes collecting and analyzing reports of adverse drug reactions from healthcare professionals and the public, as well as monitoring the quality of manufactured drugs through inspections and product testing.

Furthermore, lääkevalvonta plays a crucial role in regulating the promotion and information related to medicines, ensuring that advertising is accurate and not misleading. It also oversees the distribution and dispensing of medicines, including prescription requirements and the activities of pharmacies. The overarching goal of lääkevalvonta is to protect public health by ensuring that all medicines available in Finland meet high standards and are used appropriately. This system is a vital component of a functioning healthcare system.