Do new generations of active pharmaceuticals for human use require an adaption of the environmental risk assessment? : part I: literature review : final report / by Dr. Manfred Kohler, Sebastian Stix, Dr. Björn Windshügel, Oliver Keminer, Azora König, Dr. Lena Kosak, Dr. Elke Eilebrecht (Fraunhofer Institute for Molecular Biology and Applied Ecology IME) ; on behalf of the German Environment Agency ; edited by: Section IV2.2 Arzneimittel, Wasch- und Reinigungmittel - Jasmin Brückner, Kathi Westphal-Settele (Fachbegleitung)

Abstract

Since 2006, various new active pharmaceutical ingredients have been developed with highly specific mechanisms of action. That raise the question of whether current environmental risk assessment within the scope of the authorization is still sufficient to appropriately assess relevant effects on environmental organisms. In this literature review the scientific basis for a tailored risk assessment was developed and discussed for 3 substance classes (oncology, neurology, cardiology). The proposed assessment includes additional test methods, groups of organisms and alternative endpoints. The practical review of the proposed test approaches is to be carried out using case studies in subproject 2.