EMA’S NEW GUIDELINES ON ENVIRONMENTAL RISK ASSESSMENT FOR HUMAN MEDICINAL PRODUCTS

The European Medicines Agency (EMA) has recently published a significant update to its guideline on Environmental Risk Assessment (ERA) for Medicinal Products for human use, that will be effective starting from 1^st September 2024.

This guideline explains how to conduct an ERA and assess any environmental concerns associated with the use of a pharmaceutical product. Moreover, a description is given of how to identify possible risks associated with a medication’s active ingredient. The guideline provides guidance on how to report the findings in an ERA Report and includes consideration of potential precautionary and risk mitigation measures.

One of the key changes is that for each ERA, both a risk assessment and a hazard (PBT/vPvB) assessment are now required.

• The risk assessment reflects the possibility of an effect occurring and is an evaluation of both exposure of organisms in the environment to the active substance, and ecotoxicity.
• The hazard assessment concerns the identification of intrinsic properties of an active substance that could pose harm to the environment, regardless of the levels of exposure.

An ERA is now required for all initial Marketing Authorization Applications and certain post-authorization applications (e.g. extension applications), regardless of the legal basis.

RPN offers its expertise to guide companies in the management of ERA, ensuring compliance with Health Authority standards.