The Veterinary Medicine Division supports the development of veterinary medicinal products that fall within the remit of the Paul-Ehrlich-Institut (medicinal products for animal use) within the framework of the following regulatory procedures: evaluation of immunological veterinary medicinal products and innovative immunotherapeutics, monitoring of the safety of such products, scientific advice, marketing authorisation and testing, and approval of clinical trials (field trials).
The veterinary medicinal products for use in pets, livestock, and fish included in the responsibility of the Veterinary Medicine Division are:
The Paul-Ehrlich-Institut's veterinary medicine experts actively represent the division in European committees at the European Medicines Agency (EMA), in the veterinary-specific section of the Heads of Medicines Agencies (HMA), the European Directorate for the Quality of Medicines & HealthCare (EDQM), as well as in national committees.
The Paul-Ehrlich-Institut's Animal Facilities Section is also part of this division. The section provides infrastructure for in vivo experiments for the entire Paul-Ehrlich-Institut. Such experiments are still indispensable for federal batch testing and research.
Basic research and product-related research complement the division's regulatory tasks, such as research on new prophylactic and therapeutic approaches, especially against zoonotic diseases, and the development of innovative methods for experimental product testing, in particular those designed with the aim of replacing, reducing and refining animal experiments (3R). The division works towards that goal by carrying out a research program that follows the 3R principles: "Replacement, Reduction, Refinement". The aim is to replace animal test methods that are still prescribed for experimental testing of medicinal products in the pharmacopoeia by valid laboratory test methods.
This section processes and coordinates the marketing authorisation of veterinary medicinal products within the responsibility of the Paul-Ehrlich-Institut, evaluates the quality, safety and efficacy data provided, and approves clinical trials, in which the safety and efficacy of the veterinary medicinal products are investigated under field conditions as a basis for their authorisation. More than 400 authorised immunological veterinary medicinal products are under regulatory supervision throughout their life cycle. The section also actively participates in the development of guidelines for immunological veterinary medicinal products and advises developers, manufacturers, and marketing authorisation holders on regulatory and scientific issues.
This section keeps and cares for laboratory animals, provides veterinary care, and gives internal advice on questions relating to animal experiments. These services are needed for the experimental batch testing of veterinary and human medicinal products that precedes federal batch release by the Paul-Ehrlich-Institut, in which animal experiments are required or necessary, as well as for research projects.
This section carries out the experimental batch testing of immunological veterinary medicinal products and – with the support from the section "Assessment of Immunological Veterinary Medicinal Products" – performs the Institute's federal batch release. In 2022, approval was granted for about 2,500 batches, almost 20 percent of which after internal experimental testing. This section is thus a leader in the veterinary testing field in Europe and ensures the consistent quality and efficacy of these veterinary medicinal products. Furthermore, this section focusses on improving test methods and researches the safety and efficacy of viral vector systems for the control of illness, primarily zoonotic infectious diseases and tumour diseases.
This section registers, reviews, and evaluates reported suspected adverse reactions following the administration of immunological veterinary medicinal products. The aim of monitoring adverse reactions (veterinary pharmacovigilance) is to identify medicinal product risks at an early stage, to assess them scientifically, and to take, coordinate, or initiate any necessary measures to minimise any risks. This section also advises on issues relating to the safety of immunological veterinary medicinal products.
This section supports the development of new methods of experimental medicinal product testing and explores virus-host interactions in animal models/surrogate models to investigate mechanisms of disease in humans and animals that could form the basis for the development of new vaccines and therapeutics.
Email: veterinaermedizin@pei.de
Updated: 22.08.2024
