This paper analyzes three special regulatory systems for regenerative medicine(RM)products in Japan,including Conditional and Time-limited approval procedure,the SAKIGAKE designation system,and the Orphan Drug Designation system.The study explores the specific content and current implementation status of these innovative regulatory policies.At the same time,a comparative analysis is conducted between Japan and China's regulatory policies and their implementation,identifying challenges faced by China's cell and gene therapy(CGT)product regulation.The paper also discusses the insights that can be drawn from Japan's policies for improving China's regulatory framework.
关键词
再生医学产品/监管政策/日本/创新/启示
Key words
regenerative medicine products/regulatory policies/Japan/innovation/insights
维普
万方数据