• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

Conditional early approval for new drug applications in Japan: Current and emerging issues.

作者信息

Tanaka Mototsugu, Miyazawa Haruna, Terashima Ryohei, Ikuma Mutsuhiro

机构信息

Clinical and Translational Research Center, Niigata University Medical and Dental Hospital, Niigata, Japan.

Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

出版信息

Clin Transl Sci. 2023 Aug;16(8):1289-1293. doi: 10.1111/cts.13536. Epub 2023 May 10.

DOI:10.1111/cts.13536
PMID:37161871
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10432865/
Abstract
摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4733/10432865/7afe58ba5ab9/CTS-16-1289-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4733/10432865/7afe58ba5ab9/CTS-16-1289-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4733/10432865/7afe58ba5ab9/CTS-16-1289-g001.jpg

相似文献

1
Conditional early approval for new drug applications in Japan: Current and emerging issues.日本新药申请的有条件早期批准：当前及新出现的问题
Clin Transl Sci. 2023 Aug;16(8):1289-1293. doi: 10.1111/cts.13536. Epub 2023 May 10.
2
Regulatory issues and the potential use of Bayesian approaches for early drug approval systems in Japan.日本早期药物审批系统的监管问题及贝叶斯方法的潜在应用。
Pharm Stat. 2022 May;21(3):691-695. doi: 10.1002/pst.2192. Epub 2022 Jan 7.
3
[Pharmaceutical approval process of drugs for hematological malignancies: current situations in Japan].[血液系统恶性肿瘤药物的药品审批流程：日本现状]
Rinsho Ketsueki. 2020;61(5):437-444. doi: 10.11406/rinketsu.61.437.
4
Conditional approval: Japan lowers the bar for regenerative medicine products.有条件批准：日本降低再生医学产品标准。
Cell Stem Cell. 2015 Apr 2;16(4):353-6. doi: 10.1016/j.stem.2015.03.013.
5
Overview of the Premarketing and Postmarketing Requirements for Drugs Granted Japanese Conditional Marketing Approval.简述获得日本有条件批准上市药品的上市前和上市后要求。
Clin Transl Sci. 2021 May;14(3):806-811. doi: 10.1111/cts.12898. Epub 2021 Apr 3.
6
Japanese regulatory system for approval of off-label drug use: evaluation of safety and effectiveness in literature-based applications.日本药品标签外使用批准的监管体系：基于文献申请的安全性和有效性评估。
Clin Ther. 2012 Oct;34(10):2104-16. doi: 10.1016/j.clinthera.2012.09.004. Epub 2012 Oct 2.
7
Characteristics of drugs approved in Japan without conducting confirmatory clinical trials.在日本获得批准的药品而未进行确证性临床试验的特点。
J Clin Pharm Ther. 2021 Dec;46(6):1582-1590. doi: 10.1111/jcpt.13487. Epub 2021 Jul 11.
8
Approval of new drugs 1999-2007: comparison of the US, the EU and Japan situations.1999-2007 年新药审批：美国、欧盟和日本情况比较。
J Clin Pharm Ther. 2010 Jun;35(3):289-301. doi: 10.1111/j.1365-2710.2009.01099.x.
9
Rationales of delay and difference in regulatory review by Japan, the USA and Europe among new drugs first approved in Japan.日本、美国和欧洲对日本首次批准的新药在监管审查中延迟和差异的理由。
Br J Clin Pharmacol. 2021 Aug;87(8):3279-3291. doi: 10.1111/bcp.14749. Epub 2021 Mar 5.
10
Oncology drug clinical development and approval in Japan: the role of the pharmaceuticals and medical devices evaluation center (PMDEC).日本肿瘤药物的临床开发与审批：药品和医疗器械评估中心（PMDEC）的作用
Crit Rev Oncol Hematol. 2002 May;42(2):145-55. doi: 10.1016/s1040-8428(02)00010-0.

引用本文的文献

1
Stem cell therapies for diabetes.糖尿病的干细胞疗法。
Nat Med. 2025 Jun 27. doi: 10.1038/s41591-025-03767-8.
2
Approval of high-benefit oncology drugs in Japan: utilization of expedited regulatory pathways for the accelerated approved anticancer drugs.日本高疗效肿瘤药物的批准：加速批准的抗癌药物对快速监管途径的利用
Invest New Drugs. 2025 Jun 4. doi: 10.1007/s10637-025-01549-0.
3
Clinical Evidence of Mesenchymal Stromal Cells for Cerebral Palsy: Scoping Review with Meta-Analysis of Efficacy in Gross Motor Outcomes.间充质基质细胞治疗脑性瘫痪的临床证据：对粗大运动功能结局疗效进行Meta分析的范围综述

本文引用的文献

1
US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018.美国食品和药物管理局在 1992 年至 2018 年间对非肿瘤药物适应症的加速审批计划。
JAMA Netw Open. 2022 Sep 1;5(9):e2230973. doi: 10.1001/jamanetworkopen.2022.30973.
2
Accelerated Approval - Taking the FDA's Concerns Seriously.加速批准——认真对待美国食品药品监督管理局的担忧。
N Engl J Med. 2022 Jul 21;387(3):199-201. doi: 10.1056/NEJMp2204487. Epub 2022 Jul 6.
3
Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis.
Cells. 2025 May 12;14(10):700. doi: 10.3390/cells14100700.
4
Evaluation of drug lag and drug loss in Japan: participation in global phase III oncology trials.日本药物滞后与药物损失评估：参与全球III期肿瘤学试验
Int J Clin Oncol. 2025 Apr 11. doi: 10.1007/s10147-025-02756-8.
5
US FDA-accelerated approvals and subsequent withdrawals: influence on Japanese clinical oncology practice guidelines.美国食品药品监督管理局加速批准及后续撤回：对日本临床肿瘤学实践指南的影响
Invest New Drugs. 2025 Apr;43(2):311-317. doi: 10.1007/s10637-025-01524-9. Epub 2025 Apr 3.
6
Verifying Clinical Benefit of New Anticancer Drugs After Regulatory Approval Based on Exploratory Studies.基于探索性研究验证新抗癌药物在监管批准后的临床益处。
Ther Innov Regul Sci. 2025 May;59(3):542-548. doi: 10.1007/s43441-025-00757-3. Epub 2025 Feb 10.
7
The Icarian flight of antibody-drug conjugates: target selection amidst complexity and tackling adverse impacts.抗体药物偶联物的伊卡洛斯式飞行：在复杂性中进行靶点选择并应对不良反应
Protein Cell. 2025 Jan 15. doi: 10.1093/procel/pwaf002.
8
Continued cancer drug approvals in Japan and Europe after market withdrawal in the United States: A comparative study of accelerated approvals.美国市场撤市后日本和欧洲继续批准抗癌药物：加速批准的比较研究。
Clin Transl Sci. 2024 Jul;17(7):e13879. doi: 10.1111/cts.13879.
9
Recent Status of Phase I Clinical Trials for Brain Tumors: A Regulatory Science Study of Exploratory Efficacy Endpoints.脑肿瘤 I 期临床试验的最新现状：探索性疗效终点的监管科学研究。
Ther Innov Regul Sci. 2024 Jul;58(4):655-662. doi: 10.1007/s43441-024-00644-3. Epub 2024 Mar 26.
日本新药审批格局的演变及其与国际上市日期的差距：回顾性监管分析。
Clin Pharmacol Ther. 2021 May;109(5):1265-1273. doi: 10.1002/cpt.2080. Epub 2020 Nov 15.
4
A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.美国食品和药物管理局加速批准恶性血液病和肿瘤药物和生物制剂的 25 年经验：综述。
JAMA Oncol. 2018 Jun 1;4(6):849-856. doi: 10.1001/jamaoncol.2017.5618.