Research and Insights on the Innovative Regulatory Polices for Regenerative Medicine Products in Japan
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.
regenerative medicine productsregulatory policiesJapaninnovationinsights
万方数据
维普
