All Environmental risk assessment (ERA) articles
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ContentsRegulatory Rapporteur July/August 2026 – Contents
The July/August issue of Regulatory Rapporteur focuses on therapeutics.
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EditorialTherapeutics: Navigating diverse regulatory pathways
This July/August issue of Regulatory Rapporteur explores how regulatory strategies are shaped by the unique demands of different therapeutic areas. From oncology, rare diseases and paediatrics to influenza, fertility and vaccine safety, we examine the evolving pathways, challenges and opportunities facing product development. Together, these articles highlight the critical role regulatory professionals play in navigating complex and often divergent requirements to support innovation and deliver safe, effective therapies to patients worldwide.
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JournalEnvironmental risk assessment of human medicinal products in the EU: Legacy APIs, data reuse, and the governance bottleneck after the 2024 guideline revision
The 2024 revision of the EU environmental risk assessment (ERA) guideline extended requirements to all new marketing authorisation applications, including generics and hybrids. This article discusses the obstacles in pharmaceutical ERA, and the implications for regulatory efficiency, environmental protection, ethical use and the potential for improved ERA data reuse.
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PodcastsRegRapPod − In Conversation with Bengt Mattson
BONUS EPISODE: In Conversation talking sustainability with Bengt Mattson
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Industry newsEMA future ‘VetMeds’ for healthy animals and humans; seminar
In the lead up to the EMA’s Veterinary Awareness Day, Ivo Claassen sits down to discuss the agency’s progress in the field of veterinary medicines.
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