Environmental Risk Assessment Steps

The Environmental Risk Assessment (ERA) service from Charles River is based on European guidelines; however, it can be applied to other submissions in differing countries and regulatory agencies. We have experience in ERA for all industry product sectors, including human pharmaceuticals.

Regulatory Considerations for Environmental Risk Assessment

syringe in vial of vaccieneLearn more about the requirements regulatory authorities put on pharmaceutical companies to assess the potential impact of their drug substance on the environment.

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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

  • 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.