EMA has published a revision of its guideline on Environmental Risk Assessments (ERAs) for human medicinal products. ERAs evaluate the potential impact of pharmaceuticals on the environment. The assessment is based on the use of the product and the physico-chemical, ecotoxicological and fate properties of its active substance(s). An ERA is required for all new MAAs for a medicinal product submitted through an EU-centralised, mutual recognition, decentralised or national procedure. Also, updates of the ERA can be required when submitting major variations.
The revised guideline contains decision trees to guide applicants towards the assessment strategy that should be followed. Risk assessments are divided into Phase I and Phase II assessments. In case of relatively low environmental risk, a Phase I ERA is sufficient. If a more extensive assessment is required, it can either consist of a more standard Phase II assessment or a tailored assessment. A tailored testing strategy is needed for certain substances with a specific Mode of Action (MoA), such as for antibacterial, antiparasitic and endocrine active substances.
The revision of the guidance will come into effect on 1 September 2024. I you want to learn more about this topic, don’t hesitate to reach out via our Contact page.