Environmental risk assessment in the EU regulation of medicines for human use: an analysis of stakeholder perspectives on its current and future role

Abstract

An environmental risk assessment (ERA) is mandatory for all applications for marketing authorisation of medicines in the European Union (EU). We investigated stakeholder perspectives on the role of the ERA in EU regulation of medicines for human use. We discuss the current position of the ERA and the current conduct and assessment of the ERA, such as the required expertise, data, and studies, its applicability to generic drugs, and its use in regulatory decision-making. We also discuss future perspectives, including extension of the ERA to cover antimicrobial resistance, improved risk mitigation, impact on ‘over-the-counter’ (OTC) status, and incorporation into reimbursement considerations.