China tightens the reins on clinical trials

One of the big biotech stories of the 2020s has been the rise of China. A recent survey of industry leaders found broad agreement that the US now lags behind China in clinical development of new drugs, and two years ago China oversaw more clinical trials than the US for the first time. This has led a lot of observers, like Congress’s National Security Commission on Emerging Biotechnology, to urge emulation of some of China’s regulatory approaches to drug development, like letting investigators initiate phase I trials without needing regulator approval first.

But Stat’s Brian Yang reports that China may be moving in the opposite direction, toward stricter regulation. Essentially, two deaths in gene therapy trials, and the bungled attempt by their investigators to cover up the deaths, pushed the Chinese government last October to advance Order 818. The order represents an across-the-board tightening of Chinese trial regulation. Now, investigator-initiated trials are restricted to the highest-ranked subset of hospitals, limited to certain types of drug designs, and required to meet “good manufacturing practices” standards akin to those the FDA requires of commercially available drugs in the US.

Yang finds that the rules may already be slowing down the famously fast-paced Chinese biotech center: “Since May, the China National Center for Biotechnology Development, an organization under the National Health Commission, has approved 80 or so [investigator-initiated] projects, but a STAT tally showed nearly all of them were retroactive registrations of work that had already been underway, and all of them are testing cell therapies. Only one is genuinely new.”