Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
The Bundesinstitut für Arzneimittel und Medizinprodukte, commonly known as BfArM, is the German Federal Institute for Drugs and Medical Devices. It operates under the Federal Ministry of Health in Germany.
Functions and Responsibilities:
BfArM is responsible for the regulation of medicinal products and medical devices in Germany. It ensures that pharmaceuticals meet stringent safety, efficacy, and quality standards before they are authorized for market entry. The institute also regulates medical devices, overseeing their market surveillance and conformity assessment to ensure safety and performance.
One of BfArM’s key responsibilities is pharmacovigilance, which involves the continuous monitoring of drugs and medical devices after they have been authorized. The institute collects and evaluates data on adverse effects to maintain ongoing safety and efficacy standards.
