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]

Headquarters

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 offers reliable medical knowledge via the internet, oversees medical classifications and terminology that are important for health telematics and is 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.[4]

See also

References
  1. About us, BfArM Website, Retrieved: May 11, 2020
  2. Head, BfArM Website, Retrieved: May 11, 2020
  3. Portfolio of the BMG, BfArM Website, Retrieved: May 11, 2020 This article incorporates text from this source, which is in the public domain.
  4. Kathie Clark (February 3, 2010). "European Agency Roundup". The eCTD summit.


This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.