Paul-Ehrlich-Institut

The Paul-Ehrlich-Institut is an institution of the Federal Republic of Germany. It reports to the Bundesministerium für Gesundheit (Federal Ministry of Health). Most of its activities relate to the various duties laid down in German and European medicinal product legislation, such as for example the approval of clinical trials and the marketing authorisation of particular groups of medicinal products. Since its foundation more than a hundred years ago the Paul-Ehrlich-Institut has concentrated on biological medicinal products: 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, i.e. for processes in the latest forms of biomedical treatment. These approval and marketing authorisation activities, together with the recording and assessment of undesirable effects (pharmacovigilance), are aimed at making medicinal products with a positive benefit/risk ratio available to the population. The Paul-Ehrlich-Institut also performs official experimental batch testing independently of the manufacturer, thus providing an essential contribution to the safety of biological medicinal products. A similar task is carried out by a testing laboratory at the Paul-Ehrlich-Institut, primarily for in vitro diagnostic medical devices that are used for the safety of blood and blood products. The Institution's own experimental research in the field of life sciences is an indispensable basis for the fulfillment of these duties. According to the assessment of the Wissenschaftsrat (the scientific advisory body of the German Federal Government) in 2000, this research makes a decisive contribution to the competence of the Paul-Ehrlich-Institut. It is also an essential requirement for being able to provide advisory functions at the national (Federal Government, German states) and international level (World Health Organization, European Medicines Agency, European Commission, Council of Europe and others) in a responsible and expert fashion.