The Paul-Ehrlich-Institut (PEI) is an institution of the Federal Republic of Germany and a medical regulatory body. The Federal Institute for Vaccines and Biomedicines reports to the Federal Ministry of Health (in German, Bundesministerium für Gesundheit).
The regulatory tasks of the Paul-Ehrlich-Institut include the marketing authorisation of particular groups of medicinal products and the approval of clinical trials.[1] The medicinal products in the responsibility of the PEI are: vaccines for humans and animals, medicinal products containing antibodies, allergens for therapy and diagnostics, blood and blood products and more recently, tissue and medicinal products for gene therapy, somatic cell therapy and xenogenic cell therapy.
The Institut is located in Langen, Hesse and named after the German scientist and its first director Paul Ehrlich.[2]