The Paul-Ehrlich-Institut is the Federal Institute for Vaccines and Biomedicines. It is a senior federal authority in the field of medicinal products providing services in public health.
The Paul-Ehrlich-Institut assesses and monitors the benefit-risk balance before, during and after the marketing authorisation of biomedicines for human use and immunological medicines for veterinary use.
The Paul-Ehrlich-Institut’s own experimental research in the field of life sciences is an indispensable basis for the fulfilment its duties. The Paul-Ehrlich-Institut reports to the German Federal Ministry of Health (Bundesministerium für Gesundheit).
Medicinal products within the scope of the Paul-Ehrlich-Institut
The Paul-Ehrlich-Institut assesses and monitors the following medicines for human use:
- Vaccines for the prevention of infectious diseases,
- Antibodies and immunoglobulins (sera) for the treatment of a number of diseases including cancer, rheumatism, autoimmune diseases, and neurological diseases,
- Therapeutic and diagnostic allergens,
- Advanced therapy medicinal products (ATMP) including gene therapeutics, somatic cell therapeutics, tissue engineered products (TEP) and xenogeneic medicinal products,
- Blood products and stem cell preparations,
- Tissue preparations.
The Paul-Ehrlich-Institut also assesses and monitors immunological medicines for veterinary use. These include
- Other immunological veterinary medicines, such as immunomodulators and sera for veterinary use
Please click here for a complete list of medicines within the Paul-Ehrlich-Institut’s scope.
The Paul-Ehrlich-Institut’s key duties include
- Marketing authorisation for biomedicines,
- Authorisation of clinical trials,
- Manufacturer-independent official experimental batch release testing,
- Scientific advice prior to the submission of applications for marketing authorisation or clinical trials,
- Collection and evaluation of reports of adverse reactions to medicinal products (pharmacovigilance),
- Implementation and coordination of necessary measures for preventing public and animal health hazards,
- Fundamental and applied research relating to the groups of medicinal products within the scope of the Paul-Ehrlich-Institut.
The Paul-Ehrlich-Institut assesses and monitors vaccines and biomedicines to ensure that all biomedicines available on the German and European markets have a favourable benefit-risk ratio. These activities include the assessment of documents submitted, as well as experimental tests, such as batch release testing, and on-site inspections of manufacturing facilities.
The Paul-Ehrlich-Institut employs some 800 staff and reports to the German Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). The Paul-Ehrlich-Institut also provides advice to national (federal government, federal states (Länder)) and international bodies (World Health Organisation (WHO), European Medicines Agency (EMA), European Commission, Council of Europe, etc.).
The Paul-Ehrlich-Institut hosts two WHO Collaborating Centres – one for the standardisation and evaluation of vaccines and the other for blood products and in-vitro diagnostic devices.
Marketing authorisation for and trade with medicinal products for the European market have been harmonised and are subject to extensive European regulations. This has resulted in a great number of additional responsibilities for the Paul-Ehrlich-Institut.
Please click here for an overview of all official responsibilities of the Paul-Ehrlich-Institut.
The Paul-Ehrlich-Institut has won international recognition for combining regulation of medicines, regulatory research and fundamental research.
High-level fundamental research leads to a better understanding of the mechanisms of action of medicines and initiates novel therapeutic approaches in biomedicine.
Researchers at the Paul-Ehrlich-Institut develop new methods and major reference materials for testing vaccines and biomedicines. Furthermore, they investigate the causes of unexpected adverse effects, thus playing a major part in their future prevention.
The Paul-Ehrlich-Institut’s research activities focus on three key cross-divisional research areas:
- Regulatory Research & Innovative Medicinal Product Testing
- Pathogen-Host & Biomedicine-Organism Interactions
- Experimental Vaccines, Therapies & Diagnostics.
Please click here for further information on research at the Paul-Ehrlich-Institut.