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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.

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China Plans Clinical Data Protection By Product Category For First Time

 
• By Xu Hu

After almost seven years, China’s NMPA has once again published draft measures for clinical trial data protection, opening these up to public comments. While specific protection periods by drug category are proposed, some clarifications are still needed.

China Approvals Rise But Conditional-To-Full Conversion Slips

 
• By Xu Hu

A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.

Elevar/Hengrui’s Second US CRL A Bad Omen For Multiregional Trials In Asia-Dominant Cancers?

 
• By Dexter Jie Yan

While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.

China Signals Commercial Insurance, Biotech And Foreign-Owned Hospitals As Policy Priorities

 
• By Xu Hu

The main 2025 policy priorities for China's government as outlined in an annual report will include the strengthening of commercial insurance for innovative drugs and opening up cell and gene therapy and the hospital sector to foreign investment.

More from Asia

Japan Identifies Drugs ‘In Urgent Need’ Of Development

 
• By Lisa Takagi

Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

 
• By Jung Won Shin

Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.

Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
• By Vibha Ravi

Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?