Environmental risk assessment of medicinal products for human use

As of 1 September 2024, the European Medicines Agency (EMA) has implemented a new Environmental Risk Assessment (ERA) guideline for medicinal products for human use. This mandatory assessment is required for all new marketing authorization applications (MAAs) across centralized, mutual recognition, decentralized, and national procedures.

The ERA evaluates environmental risks associated with the active substances of medicinal products, with the aim of protecting ecosystems such as surface water, groundwater, soil, and species at risk of secondary poisoning. It also considers the impact on microbial processes in sewage treatment plants.

The guideline outlines the stepwise procedure for performing the ERA, focusing on the chemical-physical characterization, environmental fate, and ecotoxicology of the active substances.

The guideline also addresses precautionary measures and risk mitigation strategies, ensuring that potential environmental impacts are identified and mitigated early in the product lifecycle. The ERA is documented in a report submitted as part of the MAA. For type II variations and extensions, the ERA dossier must be updated if there is an anticipated increase in environmental exposure. However, no ERA is required for renewals unless new data indicates otherwise.

This regulation aligns the pharmaceutical industry with Europe’s sustainability and environmental protection goals, fostering a balance between public health and ecological preservation.

For further details, view the full guideline on the EMA website.