The Federal Institute for Drugs and Medical Devices (in German: Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM) is the medical regulatory body in Germany.
The core tasks of the BfArM as a regulatory authority include the approval and registration of medical devices and products, including drugs in the special therapeutic areas of herbalism and paraherbals, as well as the identification, assessment and defence against drug risks (pharmacovigilance).
With the dissolution of the German Institute for Medical Documentation and Information (DIMDI) in May 2020, responsibility for the electronic sperm donor register was transferred to the BfArM, as was the publication and maintenance of medical classifications such as the International Statistical Classification of Diseases and Related Health Problems (ICD).
In 2010, the Federal Institute for Drugs and Medical Devices announced that it would accept pure electronic filings (eCTD or NeeS) from mid-February 2010 onward (previously a full paper copy was required).
[4] It offered reliable medical knowledge via the internet, oversaw medical classifications, terminology for health telematics and was responsible for a Health Technology Assessment programme.