目的 为我国改良型新药政策改革提供建议,落实新化药注册分类管理,合理分配注册审评监管资源,最终深化审评审批制度改革。方法 对美国505(b)(2)路径下改良型新药政策进行解读,辨析创新药、改良型新药及仿制药申报关键性特点。结合典型案例提炼制度关键点,细分不同申请类别适用情形。最终与我国新药注册制度进行对比分析,发现政策改革方向。结果 政策影响下美国改良型新药上市数量上升;研发者减免重复研究,聚焦药品的改良发展;产业保持创新态势;新药注册体系严密,各类申报呈现差异性;产品产权界定清晰,鼓舞研发热情。结论 我国亦有改良型新药申报通道特殊化设计的必要性,定位于促进临床改良,减免重复研究并完善产权保障。
Abstract
OBJECTIVE To give advices on the reform of China′s modified new drug policy and implement the design of chemical drug registration classification. METHODS This paper provides an overview of the 505(b)(2) regulatory pathway with a focus on how modified new drug applications can be submitted. This paper also analyzes the key characteristics among the innovative drug, modified new drug and generic drug registration. This paper compares these key points with China′s new drug registration system and proposes the road to reform. RESULTS The policy promotes the R&D of the modified new drugs and the development of the pharmaceutical industry. Sponsors can use existing public data in lieu of conducting studies and focus on product innovation. Features are quite different among these three applications in the registration system. The property rights of the modified products are clearly defined. CONCLUSION It′s necessary for China to legislate regulations of modified new drug. The policy is positioned to promote clinical improvement, reduces duplication of research and improves property rights protection.
关键词
改良型新药 /
505(b)(2)路径 /
政策框架 /
新药注册
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Key words
modified new drug /
505(b)(2) application /
policy framework /
new drug registration
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中图分类号：
R951
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参考文献
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