China Halts Stem-Cell Trial Applications as Regulation Tightens

Human Embryonic Stem Cells
Research using embryonic stem cells, first derived in 1999, is controversial because the cells come from human embryos donated by patients of fertility clinics. Source: NIH

China will halt new applications for clinical trials of stem-cell products until July 1 as part of a year-long campaign to regulate the development of the industry, a Ministry of Health spokesman said.

The Ministry of Health and State Food and Drug Administration are overseeing the effort, Deng Haihua, the Ministry of Health’s spokesman, said in a webcast by posted on the government website today. Medical institutions that have approved studies under way shouldn’t alter them nor charge volunteers for tests, Deng said. Trials that haven’t been approved should be stopped, he said.

China has adopted a four-way approach to build its stem-cell industry since 2007, including permissive policies on stem cells, recruiting back Chinese expatriates into local research, and providing annual funding of about $320 million, said Ipshita Chakraborty, a Calcutta-based industry analyst for Frost & Sullivan. A more stringent regulatory system will allow Chinese institutions to sell products overseas, Chakraborty said in a telephone interview.

“One industry shortcoming for a long time was a lack of a globally compliant regulatory system,” said Chakraborty, who tracks technology and investment opportunities in the stem cell space for the Mountain View, California-based consulting company. “The regulatory system is the most important, so if they focus on that, that’s good news for them: they’re putting focus on their investment in the right direction.”

Stem cells have the ability to become any type of cell in the human body, and researchers around the world are studying them to see whether they can cure disease. The potential of Chinese stem-cell research is high, Chakraborty said.

“There’s a body of research that is more than enough to commercialize,” she said.

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