BfArM - Federal Institute for Drugs and Medical Devices

For health and safety

Prof. Dr. Karl Broich TOPRA Symposium 2025

BfArM is a partner of the TOPRA Symposium 2025

In a video message, Prof. Dr. Karl Broich, President of BfArM, outlines the key topics of the international conference with PEI and BVL, taking place from 29 Sep – 1 Oct 2025 in Berlin.

DHPC (Rote-Hand-Brief) on finasteride und dutasteride

new measures to minimise the risk of suicidal thoughts

DHPC (Rote-Hand-Brief) on Isozid 0.5 N powder for solution for infusion

visual particles, use of a particle filter

DHPC (Rote-Hand-Brief) on Clozapine

Revised recommendations for routine blood count monitoring with regard to the risk of agranulocytosis

Ensuring safe care with innovative medical devices

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

Medical Research Act (MFG)

The aim of the MFG is to increase Germany's attractiveness as a location for innovative medical research. The BfArM and the PEI are working closely together to implement the programme.

Variations for Purely National Marketing Authorisations

Publication of the Joint Announcement by BfArM and PEI on the Notification of Variations for Purely National Authorisations

New validation criteria for eCTD submissions

As of 1st March 2025 new validation criteria for eCTD submissions are mandatory.

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

Finasteride- and dutasteride-containing medicines: suicidal thoughts and behaviours

2025.09.16

Direct Healthcare Professional Communication (DHPC) on finasteride und dutasteride: new measures to minimise the risk of suicidal thoughts

2025.09.15

Azithromycin: re-evaluation of the benefits and risks

2025.09.12

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 Magnet Venting Path of 3 Tesla MRI System by Siemens Shenzhen Magnetic Resonance Ltd.

Download_VeroeffentlichtAm_EN 2025.09.16 Download_Angaben zum Download PDF, 4MB, 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.