論文

査読有り 筆頭著者 責任著者 本文へのリンクあり 国際誌
2020年11月15日

Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis

Clinical Pharmacology & Therapeutics
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回数 : 172
  • Mototsugu Tanaka
  • Mayumi Idei
  • Hiroshi Sakaguchi
  • Ryosuke Kato
  • Daisuke Sato
  • Kenji Sawanobori
  • Shuichi Kawarasaki
  • Toshiyuki Hata
  • Asako Yoshizaki
  • Miki Nakamura
  • Mutsuhiro Ikuma
  • 全て表示

記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1002/cpt.2080
出版者・発行元
Wiley

The Pharmaceuticals and Medical Devices Agency (PMDA) have approved hundreds of new drugs in recent years. We retrospectively analyzed the new drugs approved in Japan from 2008 to 2019, and identify the first-in-world approvals and clarify the current drug lag. The new drug and the drug lag were defined as a drug with a new active substance and a difference between the approval date in Japan and the international birth date, respectively. Among 400 new drugs approved in Japan during the last 12 years, 80 (20.0%) were first approved in Japan, and 320 were outside Japan (the United States: 202, 50.5%; Europe: 82, 20.5%; other regions: 36, 9.0%). Of these, 45 new drugs have not yet been approved outside Japan, and the remaining 355 have been globally approved in Japan and overseas. The number of new drug approvals were the largest in oncology followed by metabolic/endocrine and infectious diseases. The median drug lags (year) among all 400 new drugs and 355 new drugs with global approvals were 4.3 and 4.7 in the 1st tertile (2008-2011), 1.5 and 2.6 in the 2nd tertile (2012-2015), and reduced to 1.3 and 2.2 in the 3rd tertile (2016-2019), respectively. Substantial drug lag remains in neurology, psychiatry, and therapeutic areas where the number of new drug approvals was relatively small. Collectively, one-fifth of the new drugs approved in Japan are first-in-world approvals. Drug lag has been greatly decreased, although it still exists.

リンク情報
DOI
https://doi.org/10.1002/cpt.2080
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/33048367
URL
https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2080
URL
https://onlinelibrary.wiley.com/doi/full-xml/10.1002/cpt.2080
ID情報
  • DOI : 10.1002/cpt.2080
  • ISSN : 0009-9236
  • eISSN : 1532-6535
  • PubMed ID : 33048367

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