China is planning to introduce a risk-based regulatory system for cell and gene therapies in the wake of the germline modification scandal. The system would require developers of high-risk therapies to get state-level clearance for clinical trials, while leaving local authorities to sign off on less-dangerous technologies.
The Chinese regulation of advanced medical technologies has been in the spotlight since a scientist claimed to have engineered the genes of human embryos to render them resistant to HIV. If true, the research would make this the first time the human germline has been genetically engineered.
Chinese authorities argue the germline work was prohibited under 2003 in-vitro fertilization rules but have nonetheless reviewed oversight of the field. The result is draft regulations and an accompanying explainer that set out how China plans to facilitate clinical research while preventing lapses in ethics, privacy, safety and other areas.
The plan is to divide up oversight by risk, thereby ensuring tougher scrutiny of programs that pose the biggest threat. Examples of high-risk programs that will be subject to state-level oversight include projects involving cells, tissues, organs, changes to genetic materials and synthetic biology. Other technically challenging projects with potentially significant impacts could be classed as high risk, too…