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 Karl Broich.^[2]

Portfolio

The Federal Institute for Drugs and Medical Devices is one of the two independent federal higher authorities in 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

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.

References

^ 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.