Hurdles of environmental risk assessment procedures for advanced therapy medicinal products: comparison between the European Union and the United States

• Published in: Critical reviews in toxicology Vol. 49; no. 7; pp. 580 - 596
• Main Authors: Iglesias-Lopez, C., Obach, M., Vallano, A., Agustí, A., Montané, J.
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 09.08.2019
• Subjects: advanced therapies; biological products; cell-based therapy; Environmental Monitoring; Environmental Policy; Environmental Pollutants; Environmental risk assessment; European Union; gene therapy; Humans; legislation and jurisprudence; Marketing; Pharmaceutical Preparations; Risk Assessment; United States; United States Food and Drug Administration; United States; advanced therapies; Environmental risk assessment; legislation and jurisprudence; European Union; cell-based therapy; gene therapy; United States Food and Drug Administration; biological products
• ISSN: 1040-8444; 1547-6898
• DOI: 10.1080/10408444.2019.1689380

An environmental risk assessment (ERA) consists of an analysis of the risks to human health and the environment that a medicinal product may cause due to its release during clinical development or after entering the market. Regulators in European Union (EU) and the United States (US) require that advanced therapy medicinal products (ATMPs) that are also genetically modified organisms (GMOs) undergo an ERA in order to be approved for marketing authorization. This work aims to review the regulatory issues that need to be taken into consideration for carrying out an ERA, comparing the EU and the US. The European regulatory framework for environmental procedures and the dissimilarities in its implementation across the Member States and its implications at a logistical level are analyzed in detail. In addition, this review provides a brief insight into the non-clinical and clinical assessments that should be carried out during the development of the product in order to conduct a successful ERA, and thus facilitate its marketing authorization and post-marketing monitoring. Finally, the need for a European harmonization regarding environmental procedures for ATMPs is discussed.