我国临床急需境外已上市药品审评审批制度的优化建议

孙潭霖; 王宇辰; 肖月; 邓勇

doi:10.6039/j.issn.1001-0408.2026.12.04

您当前的位置：

首页 >

文章列表页 >

我国临床急需境外已上市药品审评审批制度的优化建议

药事管理 | 更新时间：2026-06-26

- 我国临床急需境外已上市药品审评审批制度的优化建议
- Optimization suggestions for the review and approval system of clinically urgent overseas-marketed drugs in China
- 中国药房 2026年37卷第12期页码：1541-1546
- 作者机构：
  
  1.国家心理健康和精神卫生防治中心，北京　100029
  2.北京中医药大学国家中医药发展与战略研究院，北京　102401
  3.北京中医药大学人文学院，北京　102401
- 作者简介：
  
  助理研究员，博士。研究方向：医药卫生政策法律。E-mail：stl_twh@qq.com
  研究员。研究方向：医药卫生政策。E-mail：moonxy@126.com
- 基金信息：
  
  国家社会科学基金一般项目(20BGL274)
- DOI：10.6039/j.issn.1001-0408.2026.12.04
  中图分类号： R95
- 收稿：2026-02-05，
  
  修回：2026-02-27，
  
  录用：2026-06-12，
  
  纸质出版：2026-06-30
- 稿件说明：
移动端阅览
孙潭霖,王宇辰,肖月,等.我国临床急需境外已上市药品审评审批制度的优化建议[J].中国药房,2026,37(12):1541-1546.

SUN Tanlin,WANG Yuchen,XIAO Yue,et al.Optimization suggestions for the review and approval system of clinically urgent overseas-marketed drugs in China[J].ZHONGGUO YAOFANG,2026,37(12):1541-1546.
孙潭霖,王宇辰,肖月,等.我国临床急需境外已上市药品审评审批制度的优化建议[J].中国药房,2026,37(12):1541-1546. DOI： 10.6039/j.issn.1001-0408.2026.12.04.

SUN Tanlin,WANG Yuchen,XIAO Yue,et al.Optimization suggestions for the review and approval system of clinically urgent overseas-marketed drugs in China[J].ZHONGGUO YAOFANG,2026,37(12):1541-1546. DOI： 10.6039/j.issn.1001-0408.2026.12.04.

摘要

目的

为优化我国临床急需境外已上市药品审评审批制度提供参考。

方法

剖析临床急需境外已上市药品审评审批制度的特点；运用比较研究法，对比中国与澳大利亚、瑞士、加拿大三国在临床急需资质认定（即准入资质）、审评方法、批准形式三方面的制度差异。

结果与结论

我国现行制度中沟通交流会议法律性质模糊，将资质认定功能嵌入技术咨询程序，缺乏救济渠道；药品上市前临床试验豁免与上市后确证义务脱节，且境外完整审评信息获取不足，削弱了风险控制效能；未建立基于获批时序的差异化分流机制，对全球同步研发激励不足。国际典型监管模式将准入资质、审评方法、批准形式设置为独立模块，通过药品上市前准入条件放宽与上市后附条件批准机制形成对价关系。建议我国可制定临床急需药品认定技术指导原则以明确客观裁量基准，明确沟通交流会议的法律性质并配置救济渠道，强制豁免临床试验的品种纳入附条件批准程序，并建立负面信号联动机制，同时实施基于获批时序的差异化分流，以完善我国审评审批制度。

Abstract

OBJECTIVE

To provide references for optimizing the review and approval system of clinically urgent overseas-marketed drugs in China.

METHODS

The characteristics of the review and approval system for clinically urgent overseas-marketed drugs were analyzed. A comparative research method was employed to examine differences between China and Australia， Switzerland， and Canada in three dimensions： qualification determination for clinical urgency （i.e.， access qualification）， review methods， and approval modalities.

RESULTS & CONCLUSIONS

In China’s current system， the legal nature of communication and consultation meetings is ambiguous， as the qualification determination function is embedded within technical consultation procedures without remedy channels. The pre-marketing clinical trial exemption for drugs is disconnected from the post-marketing confirmation obligation， and insufficient access to complete overseas review information weakens risk control effectiveness. A differentiated triage mechanism based on the timing of global approval has not been established， providing insufficient incentives for global simultaneous research and development. International typical regulatory models set access qualification， review methods， and approval modalities as independent modules， forming a quid pro quo relationship by relaxing pre-marketing access conditions and establishing post-marketing conditional approval mechanisms. It is recommended to formulate technical guidelines for the determination of clinically urgent drugs to clarify objective discretionary benchmarks， clarify the legal nature of communication and consultation meetings and allocate remedy channels， mandatorily include clinical trial-exempted varieties in the conditional approval procedure and establish a negative signal linkage mechanism， and implement differentiated triage based on approval timing， so as to improve China’s review and approval system.

关键词

Keywords

references

国家食品药品监督管理总局，国家卫生健康委员会 . 国家药品监督管理局　国家卫生健康委员会关于临床急需境外新药审评审批相关事宜的公告 [EB/OL ] .（ 2018-10-30 ）[ 2026-01-27 ] . https：//www.nmpa.gov.cn/directory/web/nmpa/zhuanti/ypqxgg/ggzhcfg/20181030171201646.html https://www.nmpa.gov.cn/directory/web/nmpa/zhuanti/ypqxgg/ggzhcfg/20181030171201646.html .

国家药品监督管理局药品审评中心 . 关于发布第一批临床急需境外新药名单的通知 [EB/OL ] .（ 2018-11-01 ）[ 2026-01-27 ] . https：//www.cde.org.cn/main/news/viewInfoCommon/21de8acd6c395746b041b2ad93eb5c43 https://www.cde.org.cn/main/news/viewInfoCommon/21de8acd6c395746b041b2ad93eb5c43 .

国家药品监督管理局药品审评中心 . 关于发布第二批临床急需境外新药名单的通知 [EB/OL ] .（ 2019-05-29 ）[ 2026-01-27 ] . https：//www.cde.org.cn/main/news/viewInfoCommon/82f3bf94dc2c38d1a24d851f0e44914b https://www.cde.org.cn/main/news/viewInfoCommon/82f3bf94dc2c38d1a24d851f0e44914b .

国家药品监督管理局药品审评中心 . 关于发布第三批临床急需境外新药名单的通知 [EB/OL ] . （ 2020-11-19 ）[ 2026-01-27 ] . https：//www.cde.org.cn/main/news/viewInfoCommon/08818b168ccc85db9a42a0f6623b5688 https://www.cde.org.cn/main/news/viewInfoCommon/08818b168ccc85db9a42a0f6623b5688 .

国家市场监督管理总局 . 药品注册管理办法 [EB/OL ] .（ 2020-01-22 ）[ 2026-03-30 ] . https：//www.gov.cn/gongbao/content/2020/content_5512563.htm https://www.gov.cn/gongbao/content/2020/content_5512563.htm .

国家药品监督管理局 . 国家药监局关于发布《突破性治疗药物审评工作程序（试行）》等三个文件的公告 [EB/OL ] .（ 2020-07-08 ）[ 2026-01-27 ] . https：//www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20200708151701834.html https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20200708151701834.html .

国家药品监督管理局 . 国家药监局关于进一步优化临床急需境外已上市药品审评审批有关事项的公告 [EB/OL ] .（ 2026-01-05 ）[ 2026-01-27 ] . https：//www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20260107152912184.html https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20260107152912184.html .

Centre for Innovation in Regulatory Science . Mature regulatory agency benchmarking [EB/OL ] . [ 2026-02-04 ] . https：//cirsci.org/six-agency-benchmarking/ https://cirsci.org/six-agency-benchmarking/ .

Therapeutic Goods Administration . Comparable overseas regulators（CORs）：timeframes and milestones [EB/OL ] .（ 2022-06-21 ）[ 2026-01-31 ] . https：//www.tga.gov.au/products/medicines/prescription-medicines/application-and-market-authorisation/supply-prescription-medicine/applica-tion-process-prescription-medicines/comparable-overseas-regulators/comparable-overseas-regulators-cors-timeframes-and-milestones https://www.tga.gov.au/products/medicines/prescription-medicines/application-and-market-authorisation/supply-prescription-medicine/applica-tion-process-prescription-medicines/comparable-overseas-regulators/comparable-overseas-regulators-cors-timeframes-and-milestones .

Swissmedic . Questions and answers Art . 13 TPA[EB/OL ] .（ 2026-03-01 ）[ 2026-06-09 ] . https：//www.swissmedic.ch/swissmedic/en/home/services/documents/faq-art-13.html https://www.swissmedic.ch/swissmedic/en/home/services/documents/faq-art-13.html .

Swissmedic . Guidance document authorisation according to Art . 14 para. 1 abis-quaterTPA HMV4 updated[EB/OL ] .（ 2020-01-02 ）[ 2026-06-10 ] . https：//www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/information/anpassung-wl-zl-art-14.html https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/information/anpassung-wl-zl-art-14.html .

Canada gazette . Canada gazette，Part Ⅰ：Volume 159，Number 51：order providing for reliance on decisions of，or documents produced by，foreign regulatory authorities in respect of certain drugs [EB/OL ] . [ 2026-06-09 ] . https：//gazette.gc.ca/rp-pr/p1/2025/2025-12-20/html/reg4-eng.html https://gazette.gc.ca/rp-pr/p1/2025/2025-12-20/html/reg4-eng.html .

Therapeutic Goods Administration . Apply for a prescription medicine via the priority review pathway [EB/OL ] .（ 2025-05-01 ）[ 2026-06-09 ] . https：//www.tga.gov.au/products/medicines/prescription-medicines/application-and-market-authorisation/supply-prescription-medicine/applica-tion-process-prescription-medicines/apply-prescription-medicine-priority-review-pathway https://www.tga.gov.au/products/medicines/prescription-medicines/application-and-market-authorisation/supply-prescription-medicine/applica-tion-process-prescription-medicines/apply-prescription-medicine-priority-review-pathway .

Therapeutic Goods Administration . Apply for a prescription medicine via the provisional registration pathway [EB/OL ] .（ 2025-05-01 ）[ 2026-06-09 ] . https：//www.tga.gov.au/products/medicines/prescription-medicines/application-and-market-authorisation/supply-prescription-medicine/applica-tion-process-prescription-medicines/apply-prescription-medicine-provisional-registration-pathway https://www.tga.gov.au/products/medicines/prescription-medicines/application-and-market-authorisation/supply-prescription-medicine/applica-tion-process-prescription-medicines/apply-prescription-medicine-provisional-registration-pathway .

Swissmedic . Changes to the guidance documents fast-track authorisation procedure and temporary authorisation for human medicinal products [EB/OL ] .（ 2024-10-15 ）[ 2026- 06-09 ] . https：//www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/information/anpassung-wl-beschleunigtes-zlverfahren-und-wl-befristete-zl.html https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/information/anpassung-wl-beschleunigtes-zlverfahren-und-wl-befristete-zl.html .

Health Canada . Guidance for industry：priority review of drug submissions [EB/OL ] .（ 2009-02-06 ）[ 2026-06-09 ] . https：//www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/priority-review/drug-submissions.html https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/priority-review/drug-submissions.html .

Health Canada . Notice of compliance with conditions（NOC/c） [EB/OL ] .（ 2017-05-04 ）[ 2026-06-09 ] . https：//www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/conditions.html https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/conditions.html .

浏览量

下载量

CSCD

文章被引用时，请邮件提醒。

提交

工具集

关联资源

大飞扬草外泌体纳米囊泡调控Nrf2/HO-1/NQO1通路改善对乙酰氨基酚诱导肝损伤的机制研究

基于非靶向代谢组学的兴安白芷不同部位差异代谢物分析

人全血中他克莫司浓度测定方法的建立及临床应用

根因分析结合知信行理论的药学服务降低儿童临床试验用药品方案违背发生率的效果评价

ω-3多不饱和脂肪酸联合氯米芬对多囊卵巢综合征患者疗效、妊娠和安全性的影响