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A pharmaceutical Environmental Risk Assessment (ERA) is built around the environmental exposure and risk questions in the applicable regulatory framework. The evidence needed depends on the active substance, product use, market and assessment phase.
The first review should establish the active substance, maximum daily use, indications, route of administration, intended market(s), and the assumptions that drive environmental exposure. These inputs determine the scope of the subsequent environmental assessment.
Phase I focuses on estimating predicted environmental concentration in surface water (PECsw) under the applicable exposure scenario. Reliable use and population information may be important when the guideline permits refinement.
Where further assessment is indicated, available fate information may include biodegradation, transformation, adsorption and other substance-specific environmental behaviour relevant to the applicable study strategy.
Effects assessment can involve ecotoxicological endpoints and the selection of the appropriate environmental compartments and organisms under the applicable guideline. The exact study package should be justified for the substance rather than copied from a generic checklist.
The final assessment should explain how exposure and effects information are integrated, identify material data gaps, document assumptions, and make the regulatory rationale traceable.
We can confirm the applicable assessment scope, available information and next steps.