Effective Waiver Strategies for Environmental Risk Assessment of Pharmaceuticals in the European Union

ACT 2022 -- An environmental risk assessment (ERA) is mandatory for marketing authorisation of pharmaceuticals in the European Union (EU), following the European Medicines Agency (EMA) guidelines. In most cases, a costly program of physico-chemical, environmental fate and effects testing is required. In the following case studies, we explore strategies for reducing the need for laboratory testing while maintaining environmental safety: (1) adjustments for dosing regimen, (2) definition of small patient populations and(3) examination of environmental fate and effects data in the public domain. The options explored herein may allow testing to be waived, while also providing necessary information to complete the mandatory ERA and gain regulatory approval.