Hurdles of environmental risk assessment procedures for advanced therapy medicinal products: comparison between the European Union and the United States
Iglesias López, Carolina (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia)
Obach, Mercè (Institut Català de la Salut)
Vallano, Antoni (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia)
Agustí Escasany, M. Antònia (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia)
Montané Mogas, Joel (Universitat Ramon Llull. Blanquerna)

Data:	2019
Resum:	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.
Drets:	Aquest material està protegit per drets d'autor i/o drets afins. Podeu utilitzar aquest material en funció del que permet la legislació de drets d'autor i drets afins d'aplicació al vostre cas. Per a d'altres usos heu d'obtenir permís del(s) titular(s) de drets.
Llengua:	Anglès
Document:	Article ; recerca ; Versió sotmesa a revisió
Matèria:	Environmental risk assessment ; European Union ; United States Food and Drug Administration ; Advanced therapies ; Biological products ; Cell-based therapy ; Legislation and jurisprudence
Publicat a:	Crit Rev Toxicol, Vol. 49, Núm. 7 (Agost 2019) , p. 580-596, ISSN 1040-8444

DOI: 10.1080/10408444.2019.1689380

Preprint 51 p, 535.9 KB

El registre apareix a les col·leccions:
Articles > Articles de recerca
Articles > Articles publicats