Project PREMIER

Any medicinal product intended for the European market requires approval by the competent authorities. An important part of medicinal product registration is the assessment of potential environmental risks. One of the aims of the PREMIER project, in which Fraunhofer ITEM is collaborating with numerous partners, is to set up a database containing ecotoxicological studies and environmental fate studies on as many active pharmaceutical ingredients as possible and allowing this data to be made available for the development of models that can be used for prediction of environmental data.

Active pharmaceutical ingredients can get into the environment through a variety of routes and can potentially be harmful to wildlife and ecosystems. In the EU, new medicines are required to undergo an environmental risk assessment (ERA). The aim of PREMIER is to deliver a better framework for assessing and characterizing the environmental risks of active pharmaceutical ingredients (APIs). This framework could be used to prioritize older (“legacy”) APIs that have never been through an ERA for further investigations. It could also be used to pick up potential environmental risks in new APIs that are still under development at an early stage. In addition, PREMIER hopes its work will contribute to greener drug design in general and will help to make environmental data on APIs more visible and accessible to all stakeholders.

Within the PREMIER project, a database containing relevant ecotoxicological and toxicological data on human pharmaceuticals that pose a potential risk to the environment will be developed. Only incomplete data of this kind are available at present.

Dr. Susanne Schwonbeck has the lead in work package 3.2 and will be in charge of evaluating the quality and relevance of the data in the PREMIER database. This verification is to ensure reliability of the data for their use in environmental risk assessment in the future. Depending on the stakeholder group, there may be different requirements for the utilization of the data. For example, water suppliers will have a different focus than companies trying to get their drugs approved and to this end need an environmental risk assessment of a human drug. In work package 4.1, she will be preparing technical assistance guidelines for stakeholders on how to use the database to meet different needs.

Furthermore, Dr. Sylvia Escher, Head of the Fraunhofer ITEM department of In-silico Toxicology, will develop a read-across approach that is aimed at closing data gaps by extrapolating relevant data from related compounds. In addition, the possibilities of interspecies extrapolation will be investigated. For example, toxicological data from a preclinical study in rodents will be extrapolated to other vertebrates such as fish, so that testing in vertebrates can be avoided in the future.