Environmental risk assessment (ERA) for marketing authorisation of veterinary and human medicinal products

Pharmaceuticals that are to be marketed in Europe must always seek marketing authorisation by the competent authorities. The environmental risk assessment (ERA) is an important part of the marketing authorisation application (MAA) dossier.

As the requirements for environmental risk assessments are constantly changing, ambiguities often arise that even the existing guidelines and general EU assessment models cannot fully resolve.

For our clients in the pharmaceutical industry, we evaluate the necessary data, draw up the ERA for the application in line with the regulatory requirements and provide support with compiling all the required documentation, developing suitable testing strategies and engaging in discussions with the competent authorities. Any experimental investigations required can be carried out by both the Fraunhofer institutes and other experienced testing institutes. 

Overview of our services

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  • Environmental risk assessment (ERA), in compliance with VICH and EMA/CVMP and EMA/CHMP guidelines
  • Performing a systematic or targeted literature review on endpoints of significance to the ERA in order to identify new information on ecotoxicity of the active substance using specific search terms and the most important search engines (e.g. SCOPUS, PubMed, Web of Science).
  • Evaluation of relevance and reliability of the ecotoxicity data and studies found according to CRED criteria; extracting data on ecotoxicity effects, bioaccumulation, adsorption and degradation in the environment, as well as physical and chemical properties, for the environmental risk assessment (ERA guideline)
  • Assessment models and testing strategies for marketing authorisation of veterinary medicinal products: Development of custom solutions that take reliability and economy into account; waiving possibilities for required tests; discussion of acceptance with the competent authorities
  • Study design, performance and monitoring to meet all testing requirements in compliance with the relevant guidelines and regulations, in cooperation with other Fraunhofer institutes and also with other experienced testing institutes
  • Responding to “List of questions” received from the competent authorities during the registration process
  • Assessing intrinsic substance properties (PBT and endocrine-disrupting chemicals)
  • Scientific and regulatory consulting
  • Preparing environmental risk assessment (ERA) monographs for human and veterinary medicinal products 


Susanne Schwonbeck

Contact Press / Media

Dr. Susanne Schwonbeck

Phone +49 511 5350-357

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