An environmental risk assessment (ERA) is required for all marketing authorisation applications for human medicinal products (Article 8(3) of Directive 2001/83/EC). This requirement applies to all new medicinal products, and new applications for generic medicinal products with a few exceptions e.g. for naturally occurring substances. The ERA is a tiered assessment (EMA 2024); this guidance was updated in 2024 further information on the changes can be found here.

We have extensive experience in assisting both proprietary and generic pharmaceutical companies in conducting ERAs in support of their market authorisation applications for both new and existing products. Our pharmaceutical ERA services include:

Initial Assessment

• Waiver statements.
• Initial hazard assessment for Persistence, Bioaccumulation and Toxicity (PBT).
• Endocrine Active Substance assessment.
• Phase I exposure assessment including evaluation of epidemiological data and refinement of the default market penetration factor, where applicable.
• Identification of existing ERAs or existing data for filling ERA data gaps. We have a standard literature search developed in conjunction with pharmaceutical industry colleagues which can be submitted alongside the ERA. Published literature will be assessed for quality using regulatory accepted approaches for assessing relevance and reliability such as Criteria for reporting and evaluating ecotoxicity Data (CRED).

Phase II ERA

• Where data gaps are apparent, we have the expertise to initiate and monitor environmental fate and effects studies on behalf of the client:
  • Obtain and compare quotes from Contract Research Organizations (CRO),
  • Advice on tiered testing; definition of testing programme,
  • Recommendations for tailored testing for antimicrobial and/or endocrine active substances,
  • Study protocol review and agreement with CRO,
  • Study monitoring,
  • Peer review of draft study reports.
• Preparation of Expert Report for submission in Module 1.6 of the dossier including exposure refinements, and recommendations for Risk Mitigation Measures.
• Pre- and post-submission support with authorities

We also prepare environmental assessments for the US Food and Drug Administration or categorical exclusions from an environmental assessment where applicable.

Other examples of projects in this area:

• Ongoing monitoring of exposure and effects data for pharmaceuticals already on the market (Eco-pharmacovigilance).
• Deriving Environmental Quality Standards for pharmaceuticals.
• Bespoke waivers e.g. using the fish plasma model or worst-case assessments for fish bioaccumulation as an alternative to animal testing.
• Environmental foresight for pharmaceutical companies.