BfArM - Federal Institute for Drugs and Medical Devices

For health and safety

DHPC (Rote-Hand-Brief) on 5-Fluorouracil (i.v.)

In patients with moderate or severe renal impairment, uracil levels measured to determine dihydropyrimidine dehydrogenase (DPD) deficiency should be interpreted with caution

Save the date – next Iris webinar

The next Iris webinar will be held on 13^th November 2024.

DHPC (Rote-Hand-Brief) on medroxyprogesterone acetate

Risk of meningioma and measures to minimise this risk

DHPC (Rote-Hand-Brief) on Oxbryta (voxelotor)

Suspension of EU marketing authorisation

European Regulatory Oncology News - ERON

The latest newsletter on innovative medicines for the treatment of cancer is available.

Update of Iris Version 5

We published a new version of the Iris software – V5.8.4-Y2024S2.

Responsibilities for IgG Fc fusion proteins

Information for Pharmaceutical Companies: PEI and BfArM have agreed to transfer primary responsibilities regarding IgG Fc fusion proteins to the BfArM.

Ensuring safe care with innovative medical devices

The European medical device authorities have published a joint statement on the MDR and IVDR.

Blog "BfArM4Health"

New blog post "Global Health Protection Programme: Monograph work on excipients for mRNA vaccines"

Classification of reserve antibiotics §35a SGB V

Update of the pathogen list and criteria by RKI and BfArM 2024

BfArM Impulse Report

AI or EU pharmaceutical legislation, the BfArM's annual report provides exciting impulses for the future of medicine.

Services

Reporting risks to the BfArM

Medicinal products

Consumers and healthcare professionals reporting adverse reactions (German)

Medical devices

SNOMED CT

SNOMED CT is currently the most comprehensive health terminology in the world, a constantly growing ontology of preferred terms with their synonyms. The national competence Center for Terminologies at BfArM is responsible for the provision and further development of SNOMED CT in Germany.

Medicinal products

Direct Healthcare Professional Communication (DHPC) on 5-Fluorouracil (i.v.): In patients with moderate or severe renal impairment, uracil levels measured to determine dihydropyrimidine dehydrogenase (DPD) deficiency should be interpreted with caution.

2024.10.24

Direct Healthcare Professional Communication (DHPC) on medroxyprogesterone acetate: Risk of meningioma and measures to minimise this risk

2024.10.09

Direct Healthcare Professional Communication (DHPC) on Oxbryta (voxelotor): Suspension of EU marketing authorisation

2024.10.07

All risk information on medicinal products

Medical devices

Critical vulnerabilities in the real-time operating systems of various venders

Date: 2021.08.19 Topics: Medical devices

All risk information on medical devices

Urgent Field Safety Notice for Lovo Disposable Kits by Fresenius Kabi AG

Download_VeroeffentlichtAm_EN 2024.11.04 Download_Angaben zum Download PDF, 140KB, File does not meet accessibility standards

All field corrective actions

In focus

DiGA and DiPA

Digital applications are an important element in the digital modernisation of health care and nursing in Germany. They are part of the future eHealth infrastructure and will interact closely with other digital elements such as the electronic health record (ePA).

Antibiotic resistances

Antibiotics are indispensable for the treatment of infectious diseases caused by bacteria. The fight against antibiotic resistance is therefore enormously important in order to ensure that patients will be optimally treated with effective drugs in the future. BfArM contributes its expertise to a number of projects and initiatives to protect "older" antibiotics and to drive forward the development and research of new antibiotics.

Europe and International

The BfArM is the largest drug approval authority in Europe. Experts contribute their knowledge to the scientific committees of the European Medicines Agency (EMA), among others. Throughout the EU and internationally, BfArM makes a significant contribution to the supply of safe and effective medicines.

Research

Research at the BfArM concentrates on important and contemporary research focal points with regard to the marketing authorisation of medicinal products and improving the safety as well as concerning the recording and assessment of risks in connection with medical devices.