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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

Marketing Authorisation of Medicinal Products Source: PEI

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

  • Vaccines,
  • 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.

Official duties

Official Duties of the Paul-Ehrlich-InstitutSource: PEI

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.


Research at the Paul-Ehrlich-InstitutSource: PEI

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.

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Additional Information

Further Information

Publications of the PEI (Source: PEI)

PEI Annual Report 2015/16


PEI Annual Report 2013/14


Institute Flyer


Flyer 'Doctors at the Paul-Ehrlich-Institut'


Latest Press Release

28.11.2018: Chromatin opening elements allow tetracycline inducible gene expression in stem cells


19.11.2018: Medicines authorities world-wide call for consistent reporting of adverse effects