Environmental Risk Assessment (ERA) for Medicinal Products intended for Human use
Under Directive 2001/83/EC, an Environmental Risk Assessment (ERA) is required for medicinal products intended for human use. This assessment evaluates the potential environmental exposure and impact of pharmaceuticals, aiming to identify and mitigate any associated risks, in a two-phased approach.
As of September 2024, the European Medicines Agency (EMA) revised its ERA guidance to include a targeted literature review as part of new marketing authorisation applications (MAAs) (EMA, 2024). This addition reduces unnecessary testing while ensuring that any new, relevant information on the active substance is identified and considered in an assessment.
