加速日本药物开发：一个PMDA的视角。

IF 5.5 2区医学 Q1 PHARMACOLOGY & PHARMACY

Clinical Pharmacology & Therapeutics Pub Date : 2025-08-04 DOI:10.1002/cpt.70022

Yoichi Kohno, Akihiro Ishiguro, Takashi Yasukawa, Naoyuki Yasuda, Daisuke Tanaka, Yasuhiro Araki, Yukio Takahashi, Yoshiaki Uyama, Yasuhiro Fujiwara

{"title":"加速日本药物开发：一个PMDA的视角。","authors":"Yoichi Kohno, Akihiro Ishiguro, Takashi Yasukawa, Naoyuki Yasuda, Daisuke Tanaka, Yasuhiro Araki, Yukio Takahashi, Yoshiaki Uyama, Yasuhiro Fujiwara","doi":"10.1002/cpt.70022","DOIUrl":null,"url":null,"abstract":"Review time for a new drug in Japan has shortened dramatically since the establishment of the Pharmaceuticals and Medical Devices Agency (PMDA). Nonetheless, Japan faces a new challenge so-called \"Drug Loss\", which means that new drugs approved overseas have not yet been developed in Japan or that development is delayed. In this manuscript, we describe how PMDA facilitates Japan's drug development to continuously provide innovative drugs to patients.","PeriodicalId":153,"journal":{"name":"Clinical Pharmacology & Therapeutics","volume":" ","pages":""},"PeriodicalIF":5.5000,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Expediting Drug Development in Japan: A PMDA Perspective.\",\"authors\":\"Yoichi Kohno, Akihiro Ishiguro, Takashi Yasukawa, Naoyuki Yasuda, Daisuke Tanaka, Yasuhiro Araki, Yukio Takahashi, Yoshiaki Uyama, Yasuhiro Fujiwara\",\"doi\":\"10.1002/cpt.70022\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Review time for a new drug in Japan has shortened dramatically since the establishment of the Pharmaceuticals and Medical Devices Agency (PMDA). Nonetheless, Japan faces a new challenge so-called \\\"Drug Loss\\\", which means that new drugs approved overseas have not yet been developed in Japan or that development is delayed. In this manuscript, we describe how PMDA facilitates Japan's drug development to continuously provide innovative drugs to patients.\",\"PeriodicalId\":153,\"journal\":{\"name\":\"Clinical Pharmacology & Therapeutics\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":5.5000,\"publicationDate\":\"2025-08-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Pharmacology & Therapeutics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/cpt.70022\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Pharmacology & Therapeutics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/cpt.70022","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

摘要

自从药品和医疗器械管理局（PMDA）成立以来，日本新药的审查时间大大缩短。然而，日本面临着一个新的挑战，即“药物损失”，即海外批准的新药尚未在日本开发或开发延迟。在这篇文章中，我们描述了PMDA如何促进日本的药物开发，不断为患者提供创新药物。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Expediting Drug Development in Japan: A PMDA Perspective.

Review time for a new drug in Japan has shortened dramatically since the establishment of the Pharmaceuticals and Medical Devices Agency (PMDA). Nonetheless, Japan faces a new challenge so-called "Drug Loss", which means that new drugs approved overseas have not yet been developed in Japan or that development is delayed. In this manuscript, we describe how PMDA facilitates Japan's drug development to continuously provide innovative drugs to patients.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Clinical Pharmacology & Therapeutics 医学-药学

CiteScore

12.70

自引率

7.50%

发文量

290

审稿时长

2 months

期刊介绍： Clinical Pharmacology & Therapeutics (CPT) is the authoritative cross-disciplinary journal in experimental and clinical medicine devoted to publishing advances in the nature, action, efficacy, and evaluation of therapeutics. CPT welcomes original Articles in the emerging areas of translational, predictive and personalized medicine; new therapeutic modalities including gene and cell therapies; pharmacogenomics, proteomics and metabolomics; bioinformation and applied systems biology complementing areas of pharmacokinetics and pharmacodynamics, human investigation and clinical trials, pharmacovigilence, pharmacoepidemiology, pharmacometrics, and population pharmacology.