中外药品应急审批制度对比研究

崔俐俊; 陈嫣婷; 费永和; 陈静; 崔俐俊; 陈嫣婷; 费永和; 陈静

doi:10.12206/j.issn.2097-2024.202310015

[1]

国家食品药品监督管理总局. 药品特别审批程序[EB/OL]. (2005-11-18)[2023-10-11]. https://gkml.samr.gov.cn/nsjg/bgt/202106/t20210630_ 331796.html.

[2]

国家药品监督管理局. 总局关于解决药品注册申请积压实行优先审评审批的意见[EB/OL]. (2016-02-26)[2023-10-11]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20160226085101295.html.

[3]

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(2020年第82号)[EB/OL]. (2020-07-08)[2023-10-11]. https://www.nmpa.gov.cn/xxgk/fgwj/ xzhgfxwj/20200708151701834.html.

[4]

国家药品监督管理局. 药品注册管理办法[EB/OL]. (2020-01-22)[2023-10-11]. https://gkml.samr.gov.cn/nsjg/fgs/202003/t20200330_313670.html.

[5]

吴忠虹, 董丽. 我国药品优先审评审批制度的现状分析[J]. 中国处方药, 2022, 20(10):29-31.

[6]

陈先红, 王闻雅. 新形势下我国药品特别审批制度的思考[J]. 中国食品药品监管, 2020(9):30-35.

[7]

国家药品监督管理局药品审评中心. 《药审中心加快创新药上市许可申请审评工作规范(试行)》[EB/OL]. (2023-03-31)[2023-10-11]. https://www.cde.org.cn/main/news/viewInfoCommon/ace377c025ad4f2bbf 94790673b2646e.

[8]

FDA. Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics[EB/OL]. (2014-05)[2023-10-11]. https://www.fda.gov/media/119748/download.

[9]

FDA. Emergency Use Authorization[EB/OL]. (2017-01-13)[2023-10-11]. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

[10]

FDA. Emergency Use Authorization--Archived Information[EB/OL]. (2022-01-24)[2023-10-11]. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information.

[11]

EMA. Conditional marketing authorisation - Report on ten years of experience at the European Medicines Agency[EB/OL]. (2017-01-23)[2023-10-11]. https://www.ema.europa.eu/system/files/documents/report/wc500219991_en.pdf.

[12]

EMA. PRIME: Analysis of the first 5 years’ experience[EB/OL]. (2022-08-05)[2023-10-11]. https://www.ema.europa.eu/system/files/documents/report/2022-03_prime_5_years_report_updated_2022-04-05-en.pdf.

[13]

PDMA. 先駆的医薬品指定制度[EB/OL]. (2020-12)[2023-10-11]. https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/tp150514-01_00001.html.

[14]

PDMA. 医薬品の先駆け審査指定制度の対象品目一覧表[EB/OL]. (2023-06)[2023-10-11]. https://www.pmda.go.jp/files/000235895.pdf.

[15]

PDMA. PMDA最新動向[EB/OL]. (2022-12)[2023-10-11]. https://www.pmda.go.jp/files/000249287.pdf.

[16]

冯媛媛, 杨悦. 我国药品优先审评制度的实施情况及建议[J]. 中国药房, 2018(29):2026-2031. doi: 10.6039/j.issn.1001-0408.2018.15.03

[17]

王颖, 张小平, 杨依晗, 胡骏. 突发公共卫生事件下的药械紧急使用授权政策思考[J]. 中国医药导刊, 2020(22):157-161.