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 efficacy; granting market authorizations; monitoring adverse events; and enforcing manufacturing and quality standards. It would also regulate clinical trials, oversee biomedicines and advanced therapies, and manage risk-management plans. The institute would be tasked with transparency and science-based decision making, aligning German procedures with European Union regulations and participating in international regulator networks.

Organizationally, the proposed structure would feature directorates or departments focused on Medicines Evaluation, Vaccines and Biomedicines, Pharmacovigilance and Risk Management, Clinical Trials Regulation, Manufacturing and Quality, Regulatory Affairs and Compliance, and Communications. A centralized framework would aim to improve coherence between drug and vaccine regulation, streamline processes, and strengthen crisis response, including rapid safety communications and pharmacovigilance reporting.

Status and debates: BfArMPEI remains a topic in policy discussions. Proponents argue that centralization could enhance efficiency, consistency, and resilience, while critics fear reduced institutional independence and transitional complexities. No formal merger has been enacted as of now.