The guidelines by the EMA’s (European Medicines Agency) CVMP (Committee for Medicinal Products for Veterinary Use), VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) and CHMP (Committee for Medicinal Products for Human Use) set out principles and standards for the technical implementation of environmental risk assessments.
For the past number of years, discussions have been ongoing in both the scientific and political spheres regarding the shortcomings of the product-based environmental risk assessment (ERA) for veterinary medicinal products currently used in the EU and types of potential alternatives. In the MONO4ERA project by EC/DG SANTE, Fraunhofer ITEM carried out a feasibility study in conjunction with other project partners. This involved analyzing and evaluating a wide range of data on applying an active substance-based approach (“monograph system”) and other potential alternatives.
This study on ERA monographs for veterinary medicinal products is currently breaking new ground in relation to developing EU legislation on environmental risk assessments for human and veterinary medicinal products — in April 2023, the EU Commission included the environmental monograph system in article 24 of the draft legislation for human medicinal products. In the future, the entirety of the data, i.e., the monographs, will also be available to the public.
Fraunhofer ITEM is actively supporting the regulatory development of environmental risk assessments for drugs, including through EU projects such as PREMIER. It also assists clients in preparing the ERA as part of their application for approval.
Fraunhofer Institute for Toxicology and Experimental Medicine