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Objective: To provide suggestions for the improvement of China's drug priority review and approval system.
Methods: Japan's pioneer designation system was analyzed through literature survey compared with China's drug priority review and approval situation.
Results: The Japanese pioneer designation system has facilitated the research and development of new drugs in Japan, accelerated the speed of new drug launches, and allowed Japan to extensively participate in international multicenter clinical trials.
Conclusion: China should actively participate in international multicenter clinical trials, designate specialized personnel to fully manage the marketing application process and promote the synergy of multiple priority review and approval mechanisms.
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目的： 为我国药品加速审评审批机制的完善提供建议。
方法： 通过文献研究法对日本先进药物认定系统进行分析，结合我国药品加速审评审批机制进行比较。
结果： 日本先进药物认定系统促进了日本新药的研发，加快了新药上市的速度，使得日本更多参与到国际多中心临床试验。
结论： 我国应该积极参与国际多中心临床试验，指定专门人员全面管理上市申请过程，促进多种加速审评审批机制协同作用。
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陈缪丰，男，硕士研究生，研究方向：医药政策法规。E-mail: 942869274@qq.com。
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陈缪丰，男，硕士研究生，研究方向：医药政策法规。E-mail: 942869274@qq.com。
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