Environmental Risk Assessment in the pharma sector: Navigating regulatory frameworks and implementation strategies

Sara Baroni, Marketing Specialist, Eurofins BioPharma Product Testing Italy, Sara.Baroni@bpt.eurofinseu.com; Linda Musitelli, Business Unit Manager, Eurofins BioPharma Product Testing Consultancy Services, Eurofins Regulatory & Consultancy Services Italy, Linda.Musitelli@bpt.eurofinseu.com

What is ERA? The Environmental Risk Assessment (ERA) evaluates the potential impact of a medicinal product, primarily its active substance and relevant metabolites, on the environment following patient use and disposal. It considers factors such as persistence, bioaccumulation, and ecotoxicity to ensure that medicines are developed and marketed responsibly, minimising environmental risk.

The ERA of medicinal products is now a key regulatory requirement for all marketing authorisation applications (MAAs) in Europe. With the implementation of the EMA’s revised guideline (Rev. 1, effective from 1 September 2024), the pharmaceutical industry faces a heightened expectation to demonstrate not only the safety and efficacy of products for patients, but also their environmental impact.

The new framework strengthens obligations across all product types — including generics — and places a particular focus on antibiotics, hormones, endocrine-active substances (EAS), and cytotoxic agents, due to their potential environmental persistence and biological activity. Regulatory authorities are already issuing deficiency letters requesting updates or additional data where previous ERA submissions do not align with the new standards.

In this evolving landscape, companies must act proactively. The ERA may need updating in the event of significant changes (e.g., dosage, indication, patient population) or increased environmental exposure. For both new and existing MAAs, a structured testing strategy is essential to ensure compliance while avoiding unnecessary studies and costs.

Eurofins BioPharma Product Testing supports pharmaceutical companies through dedicated consultancy services:

• Gap analysis of existing ERA documentation against the new guideline.
• Definition of a testing strategy that identifies only the studies truly required.
• Preparation or update of ERA dossiers (Phase I and Phase II), including risk mitigation measures and labelling recommendations.
• Expert regulatory insight based on direct feedback from EMA and national agencies, ensuring dossiers are built to meet current expectations.

By combining scientific expertise and regulatory knowhow, Eurofins BioPharma Product Testing provides a one-stop solution, from document preparation to laboratory execution, leveraging its extensive network of GLP-compliant testing facilities to perform the full range of required studies.

For more information visit: www.eurofins.it/consultancy-services/biopharma/environmental-risk-assessment-for-medicinal-products-for-human-use/