Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines

The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, makes an essential contribution to the availability and safety of effective biomedical products. The regulatory responsibilities of the institute comprise, in addition to authorising marketing, providing scientific advice on the development of medicinal products, approving clinical trials, experimental product testing and the official testing and release of batches as well as the assessment of adverse reactions to medicinal products.

The previously mentioned biomedical products include vaccines and sera for humans and animals, antibodies, blood stem cell preparations and other medicinal products derived from blood, allergens, tissue preparations as well as medicinal products for new types of therapies (genetic therapies, somatic cell therapies and biotechnologically processed tissue products) for humans. The internationally recognised research conducted by the Paul-Ehrlich-Institut in the fields of virology, immunology, allerology, haematology, cell and genetic therapy improves the quality, safety and effectiveness of biomedicines. In addition, it is essential in providing a basis for the institute’s decisions regarding the assessment and authorisation of medicinal products.