美国细胞与基因治疗产品监管制度的反思与镜鉴OA

Cell and gene therapy(CGT)products are highly innovative and technically complex medical interventions,and the design of their regulatory pathways is critical for the healthy development of the industry.As a country that pioneered such research and clinical applications,the United States has established a full-lifecycle regulatory model characterized by flexibility and safety.However,the convening of the Washington CGT Roundtable suggests that China's current regulatory framework dem-onstrates advantages in promoting innovation and improving review efficiency.Nevertheless,there remains room for improvement in China's existing CGT regulatory system.While drawing lessons from the U.S.experience,it is also necessary to critically e-valuate its limitations,taking into account China's stage of industrial development and local context,and strive to build a clear,coherent,and predictable regulatory pathway.