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 (PECSURFACEWATER) of the active substance and relevant metabolites. If PECSURFACEWATER 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 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 ensure 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