Higher federal authorities

The main tasks of the higher federal authorities (BOB) in the health care sector are the approval of clinical studies, the licensing of drugs and products and the performance of inspections and audits. In the case of clinical studies, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI) are important as higher federal authorities (BOB).

The BfArM is responsible for the approval of clinical studies (trials) with medical devices and medicinal products, for the approval of medicinal products and registration of homeopathic medicinal products. It is also responsible for performance evaluations of in-vitro diagnostics, the evaluation and risk assessment of medicinal products and medical devices and the monitoring of the traffic in narcotics.

The PEI conducts performance evaluations of high-risk in vitro diagnostic medical devices. The PEI regulates the approval of vaccines and sera, blood products and genetically engineered blood components.

While interventional studies must be approved by the higher federal authorities and the ethics committee, a notification is sufficient for non-interventional studies (NIS) or post-marketing surveillance studies.