An assessment of environmental risks associated with patient use of new human drugs is a regulatory requirement for market authorization in the US and the EU. Gradient scientists have conducted dozens of environmental risk assessments (ERAs) following US FDA or EMA guidance for a wide range of active pharmaceutical ingredients from those with relatively low toxicity to antimicrobials and endocrine-active compounds. We have also successfully prepared many claims for a categorical exclusion from a full assessment with the US FDA. To support a full ERA, Gradient scientists will select, design, and oversee environmental fate and ecotoxicity testing, develop environmental exposure and risk estimates, prepare the environmental assessment report, and respond to agency comments.
Publications:
Bamgbose, IA; Vo, J; Verslycke, T. 2025. “A Read-Across Approach to Support Environmental Assessment of Data-Poor Pharmaceuticals” (submitted).
Bamgbose, IA; Mohar, I; Verslycke, T. 2020. “Are Existing Environmental Assessment Approaches Appropriate for Novel Drug Products?” Presented at the American College of Toxicology (ACT) 41st Annual Meeting, Austin, TX, November 12-19.
Verslycke, T; Mastrocco, F; Lemay, JC. 2012. “A Concordance Assessment of Predicted No-Effect Concentration (PNEC) Aquatic Toxicity Data for Pharmaceuticals.” Presented at SETAC 6th World Congress, Berlin, Germany, May 20-24.
US FDA/European Medicines Agency Environmental Assessments
Gradient has conducted many environmental assessments with the US FDA and European Medicines Agency (EMA) to support drug approval for a wide range of active pharmaceutical ingredients, from those with relatively low toxicity to antimicrobials and endocrine-active compounds. We selected, designed, and oversaw additional environmental fate and toxicity testing to support the environmental assessments, and our environmental assessments have been accepted with limited agency comment.
Categorical Exclusion Requests
Gradient prepared requests to the US FDA for categorical exclusions from a full environmental assessment for several new drugs, based on known drug characteristics, disease prevalence information, and estimated environmental concentrations. Our requests were accepted with minimal agency comments.
Risk Assessment Framework
Gradient developed a protocol to evaluate environmental fate and human health and ecological effects from the manufacturing, use, and disposal of pharmaceuticals. Our client is using our approach to proactively establish best management practices, global regulatory compliance, and risk communication.
Critique of Proposed EU Pharmaceutical Environmental Assessment Requirements
Gradient provided two rounds of comments on the EU-proposed pharmaceutical environmental assessment requirements. We recommended a streamlined, scientifically sound, tiered fate and effects data collection and assessment program. Additionally, we provided comments on the most recent proposal to revise the existing EU guidance for environmental assessment of new human drugs.
