Environmental risk assessment (ERA) for approving veterinary and human medicinal products

Drugs that are to be marketed in Europe must always be approved by the competent authority. The environmental risk assessment (ERA) is an important part of the application for approval.

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 creating 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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  • Preparing environmental risk assessment (ERA) monographs for human and veterinary medicinal products as part of an application for approval
  • Environmental risk assessment (ERA), in compliance with VICH and EMA/CVMP and EMA/CHMP guidelines
  • Performing systematic literature reviews according to the PRISMA categories and evaluating the relevance and reliability of the data found; extracting data on ecotoxicological effects, bioaccumulation, adsorption and degradation in the environment, as well as physical and chemical properties, for the environmental risk assessment (draft ERA guideline)
  • Assessment models and testing strategies for approval 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 complaints received from the competent authorities (RMS/CMS) during the registration process
  • Assessing intrinsic substance properties (PBT and endocrine-disrupting chemicals)
  • Scientific and regulatory consulting


Susanne Schwonbeck

Contact Press / Media

Dr. Susanne Schwonbeck

Phone +49 511 5350-357

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