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Environmental risk assessment of advanced therapies containing genetically modified organisms in the EU
  • Rhys Whomsley,
  • Victoria Palmi Reig,
  • Ana Hidalgo-Simon
Rhys Whomsley
European Medicines Agency
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Victoria Palmi Reig
European Medicines Agency
Author Profile
Ana Hidalgo-Simon
European Medicines Agency
Author Profile

Abstract

Gene therapy medicinal products have the potential to provide curative treatment to many diseases with current limited therapeutic options. As advanced therapy medicinal products (ATMPs), these therapies undergo a centralised, single European Union authorisation by the European Medicines Agency, but the risks, and potential harm to the environment and population at large are weighted in each application, and different interpretations at national level exist. A streamlined procedure is now in place to facilitate a consistent approach for the assessment of the environmental risks of medicines containing genetically modified organisms. This article provides an overview of basic requirements across the EU, an overview of the new streamlined process and discusses available guidance for developers. All these initiatives are aimed to remove hurdles for ATMP developers and facilitate faster access to patients.

Peer review status:Published

18 Jun 2020Submitted to British Journal of Clinical Pharmacology
19 Jun 2020Submission Checks Completed
19 Jun 2020Assigned to Editor
30 Jun 2020Reviewer(s) Assigned
07 Sep 2020Review(s) Completed, Editorial Evaluation Pending
10 Sep 2020Editorial Decision: Revise Major
20 Jan 20211st Revision Received
22 Jan 2021Submission Checks Completed
22 Jan 2021Assigned to Editor
22 Jan 2021Review(s) Completed, Editorial Evaluation Pending
25 Jan 2021Reviewer(s) Assigned
01 Feb 2021Editorial Decision: Accept
Jun 2021Published in British Journal of Clinical Pharmacology volume 87 issue 6 on pages 2450-2458. 10.1111/bcp.14781