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Environmental Fate and Effects Assessment of Human Pharmaceuticals: Lessons Learnt from Regulatory Data by Simon Schwarz; Daniela Gildemeister; Arne Hein; Patrick Schröder; Jean Bachmann is a Environmental Science article available to read on EtoBox.

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Abstract Human pharmaceuticals are extensively studied and assessed before marketing approval. Since 2006, this also includes an assessment of environmental risks. In the European Union, this is based on the guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00 corr 2), which is currently under revision. For Germany, the German Environment Agency (UBA) is tasked with the evaluation of environmental risks of human pharmaceuticals. Applicants seeking approval of medicinal products need to submit fate and effect data, in case predicted environmental concentrations (PECs) exceed 10 ng/L in surface waters, or the substance is of specific concern through its mode of action or physico-chemical characteristics. Over the last decade, this regulatory work resulted in an internal agency database containing effect data on approximately 300 active pharmaceutical ingredients (APIs). A considerable part of this data is currently not publicly available due to property rights held by the respective applicants. The database was evaluated to draw conclusions on how the current assessment approach may be improved. The evaluation of aquatic effect dat

Who reads Environmental Fate and Effects Assessment of Human Pharmaceuticals: Lessons Learnt from Regulatory Data?

Author

Simon Schwarz; Daniela Gildemeister; Arne Hein; Patrick Schröder; Jean Bachmann

Publisher

Springer Science and Business Media LLC

Published

2021

Language

EN

Field

Environmental Science (Physical Sciences)