lääkevirasto

Lääkevirasto is a term used to describe a government agency responsible for the regulation and oversight of pharmaceutical products, including medicines intended for humans and animals. The core aim of such an agency is to ensure that medicines are safe, effective and of high quality from research and development through to distribution and post-market use.

Typical functions of a lääkevirasto include evaluating and granting marketing authorizations for new medicines, assessing manufacturing, distribution and import licensing, and enforcing compliance with good manufacturing, distribution and laboratory practices. The agency also conducts pharmacovigilance and post-market surveillance, collecting and analysing adverse drug reaction reports and taking regulatory actions such as safety alerts, recalls or label changes when necessary.

In the realm of clinical research, a lääkevirasto reviews and approves clinical trial applications and monitors trial conduct to protect participants and ensure data integrity. It may also issue guidelines for healthcare professionals, manufacturers and researchers, and provide consumer information about medicines and safety.

Lääkevirastot operate within a broader national and international framework. They collaborate with health ministries, national public health bodies and, in many regions, with European Union institutions. In the EU, medicines regulation is a shared responsibility among national competent authorities and the European Medicines Agency, with some medicines authorized centrally through EU processes. In Finland, the Finnish Medicines Agency, known as Fimea, serves as the national authority for medicines and related health products, coordinating with EU partners and aligning with EU regulations. Similar agencies exist in other countries, often with comparable mandates.