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

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

Trends Biotechnol. 2018 Jul 12. pii: S0167-7799(18)30169-0. doi: 10.1016/j.tibtech.2018.06.005. [Epub ahead of print]

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

Cathomen T1, Schüle S2, Schüßler-Lenz M2, Abou-El-Enein M3.

Author information

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

PMID:

 

30017092

 

DOI:

 

10.1016/j.tibtech.2018.06.005