Environmental Risk Assessment

Charles River’s Environmental Risk Assessment (ERA) service is based on European guidelines, however, it can be applied to other submissions in differing countries and regulatory agencies.

A Marketing Authorisation Application (MAA) for a new human pharmaceutical substance should be accompanied by an ERA, as outlined in European Union Directive 2001/83/EC. An ERA is conducted in two phases. 

Phase I calculates the Predicted Environmental Concentration in surface water (PEC_SURFACEWATER) of the active substance and/or relevant metabolites. If PEC_SURFACEWATER exceeds a set action limit, or if an expert evaluation of preclinical safety and ecotoxic potential suggests a possible environmental concern, then a Phase II environmental fate and effects analysis should be performed.

Phase II comprises two tiers:

• Tier A – generation of a base set of laboratory data to assess physical-chemical properties, environmental fate, and aquatic effects of the substance
• Tier B – extended evaluation of environmental fate and effects, triggered if Tier A results indicate there is a risk to the environment and may include bioaccumulation, sediment and soil organism testing

We have experience in ERA for all industry product sectors, including human pharmaceuticals, comprising:

• Full understanding of regulatory requirements from initial consultation and Phase I evaluation to the final ERA report
• Tailored program and study design development to meet Phase II requirements
• Liaison with appropriate regulatory authorities regarding detailed design on any applicable higher tier tests
• Modern, flexible facilities capable of accommodating long-term tests, coupled with the latest analytical equipment to assure the highest quality for all in-life and analytical study components
• Capability to assess active substances with specific modes of action, such as endocrine disruptors, with on-site expertise in fish pathology and endocrinology
• 20 year proven track record in environmental testing

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