The Federal Institute for Drugs and Medical Devices is a German federal authority responsible for the approval of medicinal products, the monitoring of medical devices, pharmacovigilance and other health and safety-related tasks within Germany. At the BfArM, roughly 1,350 employees are involved in the tasks of licensing, improving the safety of medicinal products, detecting and evaluating the risks of medical devices and monitoring the legal traffic in narcotic drugs and precursors, and conducting regulatory science. The research division of BfArM has extensive experience in regulatory research, including novel technologies for large-scale RWD analyses and in consortium leadership, e.g. of the current HORIZON Europe project Real4Reg.
Role in the project
In BRIDGE, BfArM leads WP4 and the efforts in acceptance and sustainability of the proposed solutions by the health regulatory ecosystem members. BfArM will also contribute its extensive knowledge of the European regulatory landscape to identify existing policies and regulatory frameworks to identify requirements for a sandbox and will contribute the regulatory perspective to the selection, methodological planning, and evaluation of the case studies. BfArM is also involved in the development of the MOSAIC approach, making sure that the developed framework meets regulatory needs and ensuring its applicability and acceptance in regulatory praxis.