In 2024 the Federal Institute for Drugs and Medical Devices (BfArM) celebrated its 30th anniversary. Since 1994, the agency is working to ensure the efficacy and safety of medicinal products not only in Germany, but all throughout Europe. During this time the BfArM has always operated in an environment strongly influenced by the dynamic changes in science, technology and socioeconomic environments.

The aim has always been, and continues to be, to fulfil core responsibilities to the highest standard: licencing medicinal products and improving their safety, identifying and assessing risks related to medical devices, overseeing the handling of narcotics and precursors, and managing big data volumes with a focus on interoperability and enhanced healthcare.

Advocating for the healthcare of all patients, advancing new therapeutic options, and harnessing the potential of digitalization together—these tasks drive the BfArM’s activities.

Looking to the future it is clear that the BfArM faces new challenges. One of our central tasks will be shaping and expanding the ongoing digital transformation of healthcare. To operate as effectively as possible, the BfArM leverages the opportunities presented by AI and digitalization. We see ourselves as an enabler, working to drive innovation and technological advancements. With the recently enacted “Medical Research Act”, the institute has been tasked with new responsibilities, which we are implementing in an agile approach in collaboration with the Federal Ministry of Health and the Paul Ehrlich Institute.

During these times of change, the BfArM pursues its vision: "All individuals are receiving optimal healthcare!" This vision is guided by the following principles:

• We actively support a safe, digital, sustainable, and interconnected healthcare system.
• We enable innovation and progress.
• We shape a patient-centred and future-ready healthcare system—with dedicated national and European involvement.

Thanks to our expertise, excellent networking with international partners, and a clear focus, the BfArM is well prepared for future challenges.

In the videos below you can also learn how we and our partners from European networks describe our cooperation and our future priorities.

Video Statements

Prof. Dr. Karl Broich

President of the Federal Institute for Drugs and Medical Devices (BfArM)

to the video

Emer Cooke

Executive Director of the European Medicines Agency (EMA)

to the video

Prof. Dr. Karl Lauterbach

Federal Minister of Health

to the video

Prof. Dr. María Jesús Lamas Díaz

Director of the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)

to the video

Prof. Dr. Werner Knöss

Vice President of the Federal Institute for Drugs and Medical Devices (BfArM)

to the video

Prof. Dr. Wiebke Löbker

Head of Division “Innovation Management, Administrative Offices” of the Federal Institute for Drugs and Medical Devices (BfArM)

to the video

Rainer Becker

Director of Medical Products and Innovation, Directorate-General for Health and Food Safety (DG SANTE) at the European Commission

to the video

Dr. Stefanie Weber

Head of Division “Code Systems and Registers” of the Federal Institute for Drugs and Medical Devices (BfArM)

to the video

Prof. Dr. Stefan Vieths

President of the Paul-Ehrlich-Instituts (PEI)

to the video

Dr. Michael Horn

Head of Division "Licensing 1" of the Federal Institute for Drugs and Medical Devices (BfArM)

to the video

Prof. DI Dr. Christa Wirthumer-Hoche

Chair of the Scientific Advisory Board of the Federal Institute for Drugs and Medical Devices (BfArM)

to the video

Dr. Steffen Heß

Head of Staff Unit “DaTraV/Health Data Lab” of the Federal Institute for Drugs and Medical Devices (BfArM)

to the video

We move forward

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