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

C. Iglesias-Lopez, M. Obach, A. Vallano, A. Agustí*, J. Montané

*Corresponding author for this work

Research output: Contribution to journalReview articleResearchpeer-review

3 Citations (Scopus)

Abstract

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.

Original languageAmerican English
Pages (from-to)580-596
Number of pages17
JournalCritical Reviews in Toxicology
Volume49
Issue number7
DOIs
Publication statusPublished - 9 Aug 2019

Keywords

  • advanced therapies
  • biological products
  • cell-based therapy
  • Environmental risk assessment
  • European Union
  • gene therapy
  • legislation and jurisprudence
  • United States Food and Drug Administration

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