孙权,於莲莲,张宇,张方
SUN Quan,YU Lianlian,ZHANG Yu,ZHANG Fang

• 1:沈阳药科大学工商管理学院

摘要(Abstract)：

目的 新型抗感染药物在实现患者生活质量改善方面较之于现有药物多表现为非劣效性，但对于抗击微生物耐药性(anti-microbial resistance, AMR)等社会角度，其价值显得更为重要。本文作者通过梳理国外医疗体系发达国家适用于新型抗感染药物的快速审查程序，对我国新型抗感染药物快速审查程序与各国进行对比及优劣势探析，发现我国现有模式的不足，结合国外经验为我国加快新型抗感染药物审评审批提供政策参考。方法 对比国内外适用于新型抗感染药物的快速审评审批的相关政策，为国内新新型抗感染药物快速审查制度提出优化建议。结果 美国、英国、日本、韩国、加拿大和欧盟地区的新药加速审查制度实施较早、覆盖全面且有多种加速审查模式助力新型抗感染药物获批。欧美地区还设有多个AMR相关的非政府组织与药品审查部门合作，助力新型抗感染药物获批。相比而言，我国现有新型抗感染药物快速审查通道适用条件存在重叠，缺乏弹性，审查总时长远超拟定周期，新药快速审查制度对新型抗感染药物的适用度不高。结论 我国现有新药快速审查机制无法有效助力新型抗感染药物获批，国外新型抗感染药物审评审批程序的先进经验对于我国相关部委优化新药快速审查机制具有参考价值，特别是对新型抗感染药物专设的绿色审查通道以及非社会组织的积极参与是激励新药研发单位关注抗感染药物研发的重大举措。我国应基于国情，结合国外政策体系的思路，打造更加适用于新型抗感染药物的快速审查通道，同时调动各界力量，共同加速新型抗感染药物市场准入进程。
Objective Compared with the existing drugs, the new anti-infective drugs show almost no inferiority in improving the quality of life of patients, but its value is more important in the social perspective, such as anti-microbial resistance(AMR),etc..By inquiring and sorting out the accelerated examination procedures for new anti-infective drugs formulated by foreign countries with developed medical systems, this paper compares and analyzes the accelerate examination procedures for new anti-infective drugs in China with those of other countries, aiming at finding out the shortcomings of the existing relevant systems in China and providing policy reference for speeding up the examination and approval of new anti-infective drugs in China by drawing on foreign experience.Methods To compare the relevant policies applicable to the accelerated examination and approval of new anti-infective drugs at home and abroad, and put forward optimization suggestions for the accelerated examination system of new anti-infective drugs in China.Results The United States, Britain, Japan, South Korea, Canada and the European Union implemented the accelerated examination system for new drugs earlier, covering a wide range of drugs, and there were many accelerated examination modes to help new anti-infective drugs to be approved.There are also a number of AMR-related non-governmental organizations(NGOs) in Europe and America, which cooperate with drug examination departments to help new anti-infective drugs to be approved.Through comparison, the existing channels for accelerated examination of new anti-infective drugs in China have overlapping application conditions, lack of flexibility, and the total examination time exceeds the proposed period for a long time.The rapid examination system for new drugs is not suitable for new anti-infective drugs.Conclusion China′s existing accelerate review mechanism of new drugs can′t effectively help new anti-infective drugs to be approved.The advanced experience of accelerated review of new anti-infective drugs in the above countries/regions has reference value for relevant ministries and commissions in China to optimize the rapid review mechanism of new drugs.Among various acceleration mechanisms in foreign countries, the special accelerate review channel for new anti-infective drugs and the active participation of non-governmental organizations are important measures to encourage new drug research and development units to pay attention to anti-infective drugs.China′s relevant ministries and commissions should, based on the national conditions and the ideas of foreign policy systems, optimize the accelerated examination channels for new anti-infective drugs, and mobilize all sectors of society to jointly accelerate the market access process of new anti-infective drugs.

关键词(KeyWords)： 新型抗感染药物;审评审批;加速审查;市场准入
new anti-infective drugs;review and approval;accelerate review;market access

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 孙权,於莲莲,张宇,张方
SUN Quan,YU Lianlian,ZHANG Yu,ZHANG Fang

DOI: 10.14066/j.cnki.cn21-1349/r.2021.0928

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