Abstract

The 2024 revision of the EU guideline on environmental risk assessment (ERA) for human medicinal products significantly expanded regulatory expectations by extending ERA requirements to all new marketing authorisation applications, including generics and hybrids. While these changes are frequently framed as an increase in scientific and testing demands, experience since implementation suggests that the dominant challenge lies elsewhere.

This article argues that the primary bottleneck in contemporary pharmaceutical ERA is not the generation of new environmental data, but the governance of existing environmental knowledge; specifically, issues surrounding ownership, access and the reuse of ERA data for active pharmaceutical ingredients (APIs). It examines how the continued reliance on a product-based regulatory framework, despite increasingly substance-centric scientific expectations, creates structural inefficiencies, incentives for duplication and disproportionate burdens for certain applicants. The implications for regulatory efficiency, environmental protection and the ethical use of testing resources are discussed.

Finally, potential pathways towards improved ERA reuse are explored, highlighting that meaningful gains may depend more on data governance innovation than on further incremental tightening of technical data requirements alone.