我国改良型新药研发与注册政策分析及建议

Analysis and Suggestions on the Research and Development and Registration Policy of Improved New Drugs in China

目的探讨我国改良型新药面临的新的发展机遇并提出相关政策建议。方法系统分析全球改良型新药发展的研发经济性、审批状况、临床应用性、市场发展潜力及政策性鼓励等情况,对比分析我国改良型新药研发的政策变化、研发进展、市场竞争及发展趋势,评估我国改良型新药的发展阶段,并提出建议。结果与结论我国正处于从仿制药时代向科技创新含量更高的改良型新药和创新药转型的过渡期。在产业扶持政策、药品审评审批制度改革、医保支付政策以及临床应用政策的引导下,改良型新药将成为我国创新药体系的一个重要组成部分。

Objective To investigate the new development opportunities and relevant policy suggestions for improved new drugs in China.Methods The research and development(R&D)economy,approval status,clinical applicability,market development potential and policy encouragement of the development of improved new drugs in the world were systematically analyzed,the policy changes,R&D progress,market competition and development trend of the R&D of improved new drugs in China were compared to evaluate the development stage of improved new drugs in China,and the suggestions were put forward.Results and Conclusion China is in the transition period from the era of generic drugs to improved new drugs and innovative drugs with higher technical innovation content.Under the guidance of the industrial support policies,the reform of the drug review and approval system,the medical insurance payment policies and the clinical application policies,the improved new drugs will become an important part of China′s innovative drug system.