Tasks and Organisation
The authorisation of finished medicinal products on the basis of the Medicinal Products Act (Arzneimittelgesetz, AMG) is one of the main tasks of the BfArM. In the course of these licensing procedures it reviews the health benefit, i.e. efficacy, safety, and pharmaceutical quality of the medicinal products. Furthermore, the BfArM also fulfils important tasks in connection with drug licensing on a European level. Homoeopathic drugs are either registered by the BfArM without statement of indications or are licensed with indications.
If a medicinal product is taken by many patients after having been granted marketing authorisation this can lead to the discovery of rare side effects that could not always be detected previously in the course of the clinical studies required for licensing. The pharmacovigilance division collects and evaluates such reports of adverse drug reactions. On this basis the BfArM then takes the necessary measures for patient protection.
The BfArM's tasks with regard to medical devices are mainly the central collection, analysis, and evaluation of risks arising from use or application of the devices and the co-ordination of the necessary measures to be taken. This work is based on incoming incident reports on medical devices.
The Federal Opium Agency is part of the BfArM. It grants general licenses for trading legally in narcotic drugs and precursors (i.e. substances that can be used for the manufacture of narcotic drugs) and supervises the manufacturing, cultivation, trading, import, and export thereof. In this process, the Federal Opium Agency co-operates with other international institutions that control the trade in narcotics.
Research is an integral part of the BfArM's tasks; it supports the scientific expertise of the Institute both internally and externally. A key objective of our research concept is the combination of regulatory work and research to take advantage of synergistic effects. Research work also opens new perspectives for the scientific staff of the Institute. Scientific projects at the BfArM are focused on certain defined main research areas; they are internationally competitive and meet high quality standards supporting the BfArM's role as one of the leading drug regulatory authorities in Europe.
For more information on the BfArM, please continue on the following pages: