Federal Institute for Drugs and Medical Devices
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 Prof. Dr. Karl Broich.[2]
Portfolio of the BMG[]
Alongside the Paul-Ehrlich-Institut (PEI), the BfArM is one of the two independent federal higher authorities in the German health sector. Further authorities within the portfolio of the BMG 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, makes an essential 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.
- The Deutsches Institut für Medizinische Dokumentation und Information (DIMDI) or German Institute for Medical Documentation and Information is a former agency that was merged into the BfArM in 2020.[4] It offered reliable medical knowledge via the internet, oversaw medical classifications and terminology that are important for health telematics and was responsible for a Health Technology Assessment programme.
History[]
In 2010 BfArM announced that it will accept pure electronic filings (eCTD or NeeS) from mid-February 2010 (previously a full paper copy was required). Only those documents requiring signature will be required in paper.[5]
See also[]
- 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[]
- ^ About us, BfArM Website, Retrieved: May 11, 2020
- ^ Head, BfArM Website, Retrieved: May 11, 2020
- ^ Portfolio of the BMG, BfArM Website, Retrieved: May 11, 2020 This article incorporates text from this source, which is in the public domain.
- ^ "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.
- ^ Kathie Clark (February 3, 2010). "European Agency Roundup". The eCTD summit.
External links[]
Categories:
- Federal authorities in Bonn
- Medical and health organisations based in North Rhine-Westphalia
- National agencies for drug regulation
- Regulation of medical devices
- Regulation in Germany
- Medical organization stubs