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The Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) is an independent higher federal authority within the portfolio of the Federal Ministry of Health, based in Bonn. It acts as the central licensing and supervisory authority for medicinal products and medical devices in Germany, thus making a significant contribution to the safety and efficacy of health products for patients[1][2][3].
The core tasks of the BfArM include the authorization and registration of finished medicinal products, including herbal, homeopathic and anthroposophic medicinal products, as well as medical devices. In addition, the institute records and evaluates risks of medicinal products (pharmacovigilance) and medical devices, monitors the legal trade in narcotics and precursors, and provides medical coding systems for the healthcare system, such as ICD (International Classification of Diseases) and OPS (Operation and Procedure Code)[1][2][3][4].
The BfArM pursues the goal of ensuring the protection of public health and securing the supply of safe and effective medicinal products and medical devices. As a scientific institution, it conducts independent research to further develop authorization and evaluation procedures. In an international context, the BfArM works closely with European and global authorities to promote standards and innovations in healthcare[1][2][3].
Sustainability and responsibility towards society shape the work of the BfArM. The focus is on ensuring a robust, transparent and evidence-based assessment of health products that promote both health protection and innovation. The integration of digital health applications (DiGA, DiPA) demonstrates the institute's modern approach to actively supporting digital health technologies and examining their benefits on an evidence-based basis[2].
Thus, the BfArM not only contributes to product and patient safety, but also to the promotion of an advanced and sustainable healthcare system that closely links healthcare and research and continuously develops them.
This description covers essential aspects of the organization and its tasks, based on the current information on the official BfArM website and supplementary sources[1][2][3][4].
