免疫细胞治疗领域法律风险及监管对策

Legal Risks and Regulatory Strategies in the Field of Immunotherapy

通过梳理我国免疫细胞治疗的监管沿革,并比较美国、欧盟和日本的监管经验和制度体系,提出我国在该领域存在专门性伦理审查缺乏统一规范、临床试验违规收费、行业专门性立法的供给不足和多方协同监管机制不健全的风险。从完善伦理审查监管体系,防范重大伦理风险;规范临床试验制度和流程,促进行业科学持续发展;加强立法供给和协调,完善受试者权益的法律保护;建立多方协同监管机制,保障细胞治疗的安全与规范四个方面提出对策和建议。

This paper examines the regulatory evolution of immunotherapy in China,comparing regulatory experiences and systems in the United States,the European Union,and Japan.It identifies risks in China's regulatory landscape for immunotherapy,including the lack of a unified norm for specialized ethical reviews,irregularities in clinical trial fees,insufficient industry-specific legislation,and inadequacies in multi-agency collaborative regulatory mechanisms.The paper proposes strategies and recommendations in four areas:enhancing the ethical review regulatory system to prevent significant ethical risks,standardizing clinical trial systems and processes to foster sustained scientific development in the industry,strengthening legislative supply and coordination to improve legal protection for the rights of trial participants,and establishing multi-agency collaborative regulatory mechanisms to ensure the safety and standardization of cell therapy.