美国基因编辑监管体系研究及启示

Analysis on Regulatory Mechanism of United States and Enlightenment to China

摘要:

目的 本文通过对美国基因编辑监管体系的研究,为提高我国基因编辑监管的科学性与运行效力、完善监管体系提供借鉴和参考 方法 从顶层设计、运行机制和实践经验等三个层次对美国基因编辑的监管体系进行深入挖掘 结果 美国对基因编辑研究的监管以遵循科学为基础,能及时根据技术发展的需要进行调整,特别重视监管过程的公开和透明,监管的原则清晰,边界明确、细节到位 结论 我国可以借鉴美国的监管经验,加快基因编辑的立法进程,制定科学、全面、长效、协作的监管体系,推进基因编辑技术的健康发展。

Abstract:

Objective Through the study of the American gene editing supervision system, this paper provides reference for improving the scientific and operational effectiveness of gene editing ,and improving the supervision system in China. Method: The regulatory system of gene editing in the United States is deeply explored from three aspects: The top-level design, The operation mechanism and The practical experience. Result America"s regulatory regime for gene-editing research is based on scientific compliance,be able to timely adjust according to the needs of technical development,Particular pay attention to the openness and transparency of the regulatory process,and the principles of regulation are clear, the boundaries clear and the details in place. Conclusion China can learn from the regulatory experience of the United States and accelerate the legislative process of gene editing, formulating a scientific, comprehensive, long-term and cooperative regulatory mechanism to promote the healthy development of gene editing technology in China.