Lääkeainerekister

Lääkeainerekister is a Finnish term that translates to "drug substance register" or "active pharmaceutical ingredient register." It refers to a database or system maintained to catalog and manage information about active pharmaceutical ingredients (APIs) used in medicinal products. This register is crucial for regulatory bodies, pharmaceutical companies, and healthcare professionals.

The primary purpose of a Lääkeainerekister is to ensure the quality, safety, and efficacy of medicines. It typically contains detailed information about each API, including its chemical structure, physical properties, manufacturing processes, analytical methods for quality control, and stability data. This comprehensive data helps in assessing the suitability of an API for use in pharmaceuticals and in monitoring its supply chain.

In Finland, the Lääkeainerekister is likely managed by the Finnish Medicines Agency (Fimea). Such registers are essential for the authorization and supervision of medicinal products. They facilitate regulatory reviews by providing a standardized and accessible source of information about the core components of drugs. Furthermore, by tracking APIs, the register can aid in identifying potential counterfeit drugs and ensuring compliance with international standards. Pharmaceutical manufacturers rely on these registers to confirm the identity and quality of the APIs they procure and use.