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China Further Tightens Oversight Of Human Genetic Research

More Enforcement, Reviews Coming

 
• By Brian Yang

Although the latest implementing details classify many aspects of human genetic resource handling and transfer, foreign entities are severely restricted from developing gene and gene-editing therapies in China. Legal experts say the changes combined with data transfer and recent cybersecurity legislation pose additional challenges to life science companies operating in the country.

China cyber security (yongheng19962008/Shutterstock.com)
China Restricts Foreign Gene Therapy Developers, Steps Up Human Genome Research Oversight • Source: Shutterstock

From BGI Genomics Co Ltd. to AstraZeneca PLC to WuXi AppTec, six large health sector heavyweights were fined by the Chinese Ministry of Science and Technology (MOST) for violating human genome resources administration regulations, according to a high-profile announcement in late 2018.

Since then, the Chinese regulatory agency has significantly beefed up its oversight of the area

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