The Paul-Ehrlich-Institut, PEI, assesses and monitors the benefit-risk balance before, during and after the marketing authorisation of biomedicines for human use and immunological medicines. Within the Global Health Protection Programme the PEI supports authorities and organisations in Africa with the expansion and development of regulation. In order to improve the access to safe and effective vaccinations, blood and blood products.
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:
- Other immunological veterinary medicines, such as immunomodulators and sera for veterinary use.
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 (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. It is involved in the Global Health Programme, www.pei.de/ghp
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.