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Review
. 2019 Feb;37(2):120-123.
doi: 10.1016/j.tibtech.2018.06.005. Epub 2018 Jul 13.

The Human Genome Editing Race: Loosening Regulatory Standards for Commercial Advantage?

Toni Cathomen  1 , Silke Schüle  2 , Martina Schüßler-Lenz  2 , Mohamed Abou-El-Enein  3
Affiliations
Review

The Human Genome Editing Race: Loosening Regulatory Standards for Commercial Advantage?

Toni Cathomen et al. Trends Biotechnol. 2019 Feb.

Abstract

Medicinal products based on genome editing must undergo rigorous preclinical testing and are subject to regulatory oversight for proper risk assessment prior to first evaluation in humans. We give a European perspective on the regulatory expectations to translate genome editing to the clinic to ensure their timely progress to market.

Keywords: CRISPR; clinical trials; commercialization; ethics; genome editing; regulation.

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