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The Human Genome Editing Race: Loosening Regulatory Standards for Commercial Advantage?
- Cathomen, Toni, Schüle, Silke, Schüßler-Lenz, Martina, Abou-El-Enein, Mohamed
- Trends in biotechnology 2019 v.37 no.2 pp. 120-123
- gene editing, humans, markets, risk assessment
- 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.