BfArMPEI
BfArMPEI is a proposed German federal regulatory authority envisioned to merge the existing agencies BfArM (the Federal Institute for Drugs and Medical Devices) and the Paul-Ehrlich-Institut (PEI), which regulates vaccines and biomedicines. In this concept, BfArMPEI would oversee the development, authorization, manufacture, and post-market surveillance of medicines, vaccines, and biomedicines within Germany, coordinating activities across the regulatory spectrum to ensure public health and patient safety.
The core responsibilities of BfArMPEI would include evaluating new medicines and vaccines for quality, safety, and
Organizationally, the proposed structure would feature directorates or departments focused on Medicines Evaluation, Vaccines and Biomedicines,
Status and debates: BfArMPEI remains a topic in policy discussions. Proponents argue that centralization could enhance