50°42′22″N7°08′12″E / 50.7060°N 7.1367°E /50.7060; 7.1367
| Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) | |
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| Agency overview | |
|---|---|
| Formed | 1 July 1994 (1994-07-01) |
| Jurisdiction | Government of Germany |
| Headquarters | Bonn,Germany |
| Employees | 1,350(2025) |
| Annual budget | €129.7 million(2025)[1] |
| Agency executive |
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| Parent department | Federal Ministry of Health |
| Website | Official English website |
TheFederal Institute for Drugs and Medical Devices (inGerman:Bundesinstitut für Arzneimittel und Medizinprodukte –BfArM) is themedical regulatory body inGermany. It operates under theFederal Ministry of Health (BMG). It is headquartered inBonn,Germany.[2] Its president is Karl Broich.[3]
The Federal Institute for Drugs and Medical Devices is one of the two independent federal higher authorities in theGerman health care sector alongside thePaul-Ehrlich-Institut (PEI) under theFederal Ministry of Health. It is headquartered inBonn,Germany.
The core tasks of the BfArM as aregulatory authority include the approval and registration ofmedical devices andproducts, including drugs in the special therapeutic areas ofherbalism andparaherbals, as well as the identification, assessment and defence againstdrug risks (pharmacovigilance).
The office of theGerman Pharmacopoeia Commission is based at the BfArM.[4]
With the dissolution of theGerman Institute for Medical Documentation and Information (DIMDI) in May 2020, responsibility for the electronicsperm donor register was transferred to the BfArM, as was the publication and maintenance ofmedical classifications such as theInternational Statistical Classification of Diseases and Related Health Problems (ICD).
The predecessor of the BfArM was theInstitut für Arzneimittel, which was founded on 1 July 1975 as part of the formerFederal Health Agency (BGA). The BfArM was established on 1 July 1994. When the government moved fromBonn toBerlin, theBerlin-Bonn Act provided for the relocation of the authority's headquarters from Berlin to Bonn as a compensatory measure for the federal city of Bonn.[5]
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). Only those documents requiring signature would be required in paper.[6]
In 2020, theDeutsches Institut für Medizinische Dokumentation und Information (DIMDI) or German Institute for Medical Documentation and Information was merged into the BfArM.[7] It offered reliable medical knowledge via the internet, oversaw medical classifications, terminology for healthtelematics and was responsible for a Health Technology Assessment programme.
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