Federal Institute for Drugs and Medical Devices
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) | |
Agency overview | |
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Formed | 1 July 1994 |
Jurisdiction | Government of Germany |
Headquarters | Bonn, Germany |
Employees | 1350 |
Annual budget | 121.7 million Euro (2021) |
Agency executive |
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Parent department | Federal Ministry of Health |
Website | https://www.bfarm.de/EN/ |
The Federal Institute for Drugs and Medical Devices (in German: Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM) is the medical regulatory body in Germany. It operates under the Federal Ministry of Health (BMG). It is headquartered in Bonn, Germany.[1] Its president is Karl Broich.[2]
Portfolio[edit]
The Federal Institute for Drugs and Medical Devices is one of the two independent federal higher authorities in the German health care sector alongside the Paul-Ehrlich-Institut (PEI) under the Federal Ministry of Health. It is headquartered in Bonn, Germany.
Further authorities within the portfolio of the Federal Ministry of Health are:[3]
- The Robert-Koch-Institut (RKI) is the Federal Government's central institution in the field of public health responsible for identifying, preventing and combating diseases and serves as the National Institute of Public Health.
- The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, contribution to the availability and safety of effective biomedical products.
- Improving the citizens' health is the aim of the Bundeszentrale für gesundheitliche Aufklärung (BZgA) or Federal Centre for Health Education.
History[edit]
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.[4]
In 2020, the Deutsches Institut für Medizinische Dokumentation und Information (DIMDI) or German Institute for Medical Documentation and Information was merged into the BfArM .[5] It offered reliable medical knowledge via the internet, oversaw medical classifications, terminology for health telematics and was responsible for a Health Technology Assessment programme.
See also[edit]
- Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), France
- Medicines and Healthcare products Regulatory Agency (MHRA), UK
- Food and Drug Administration (FDA), USA
- Medicinal Products
- Medical device
References[edit]
- ^ About us, BfArM Website, Retrieved: May 11, 2020
- ^ Head, BfArM Website, Retrieved: May 11, 2020
- ^ Portfolio of the BMG Archived 2020-04-14 at the Wayback Machine, BfArM Website, Retrieved: May 11, 2020 This article incorporates text from this source, which is in the public domain.
- ^ Kathie Clark (February 3, 2010). "European Agency Roundup". The eCTD summit.
- ^ "Federal Institute for Drugs and Medical Devices and major functional units of DIMDI merged". Federal Institute for Drugs and Medical Devices. 2020-05-26. Retrieved 2020-12-06.
External links[edit]