China Moves to Tighten Oversight of Cutting-Edge Biomedical Therapies
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China’s top health regulator has unveiled draft rules to tighten oversight of emerging biomedical therapies, defining “new technologies” and closing loopholes that allowed some institutions to profit from experimental treatment.
On April 19, the National Health Commission released a draft set of implementation rules for the approval of clinical translational use of new biomedical technologies, opening the document for public comment through Saturday. The draft is a supporting measure for China’s new biomedical technology regulation, known as Order No. 818, which was approved by the State Council in October and is due to take effect on May 1.
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- China's NHC released draft rules on April 19 for approving clinical use of new biomedical technologies, supporting Order No. 818 effective May 1.
- Defines eligible tech as gene/cell/organ/microbial therapy and brain-computer interfaces; excludes those with approved drugs of same mechanism, in confirmatory trials, or as medical devices.
- Tightens oversight on IITs that enabled patient charges, with applications via provincial authorities to NHC and public disclosure.
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