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
The federal city of Bonn ( lat, Bonna) is a city on the banks of the Rhine in the German state of North Rhine-Westphalia, with a population of over 300,000. About south-southeast of Cologne, Bonn is in the southernmost part of the Rhine-Ruhr ...
,
Germany. Its president is Prof. Dr. Karl Broich.
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:
* 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.
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 The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information.
The specification is based on the Common Technical Document (CTD) format ...
or NeeS) from mid-February 2010 (previously a full paper copy was required). Only those documents requiring signature will be required in paper.
See also
*
Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), France
*
Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably ...
(MHRA), UK
*
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
(FDA), USA
*
Medicinal Products
*
Medical device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
References
External links
www.bfarm.de
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
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