Literature DB >> 26239646

Closing the drug lag for new drug submission and review in Japan: An industry perspective.

A F Poirier1.   

Abstract

Previous publications have focused on drug lag in Japan and the government's initiatives to address the situation.(1) Japan is the third largest pharmaceutical market, and yet has experienced significant drug lag for many years. This article reviews the progress resulting from industry adaptation of new regulatory paradigms that include Japan in global drug development programs.
© 2015 American Society for Clinical Pharmacology and Therapeutics.

Mesh：

Year:  2015        PMID： 26239646     DOI： 10.1002/cpt.192

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


  6 in total

1.  Significant differences on submission lag following regulation reform for registration of novel therapeutic drugs in Taiwan.

Authors:  I-Chen Sun
Journal:  Invest New Drugs       Date:  2019-01-05       Impact factor: 3.850

2.  Evaluation of Drug Lags in Development Initiation, New Drug Application and Approval Between Japan and the USA and the Impact of Local Versus Multi-regional Clinical Trials.

Authors:  Satoshi Ushijima; Naoki Matsumaru; Katsura Tsukamoto
Journal:  Pharmaceut Med       Date:  2021-07-22

3.  Current Status and Open Issues Concerning Global Clinical Trials (GCTs) in Japan and East Asia.

Authors:  Koichi Miyazaki; Yasunori Sato; Hideki Hanaoka; Yoshiaki Uyama
Journal:  Clin Transl Sci       Date:  2017-07-04       Impact factor: 4.689

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

Authors:  Mototsugu Tanaka; Mayumi Idei; Hiroshi Sakaguchi; Ryosuke Kato; Daisuke Sato; Kenji Sawanobori; Shuichi Kawarasaki; Toshiyuki Hata; Asako Yoshizaki; Miki Nakamura; Mutsuhiro Ikuma
Journal:  Clin Pharmacol Ther       Date:  2020-11-15       Impact factor: 6.875

Review 5.  Toward Optimum Benefit-Risk and Reduced Access Lag For Cancer Drugs in Asia: A Global Development Framework Guided by Clinical Pharmacology Principles.

Authors:  K Venkatakrishnan; C Burgess; N Gupta; A Suri; T Takubo; X Zhou; D DeMuria; M Lehnert; K Takeyama; S Singhvi; A Milton
Journal:  Clin Transl Sci       Date:  2016-02-05       Impact factor: 4.689

6.  Drug Lag and Associated Factors for Approved Drugs in Korea Compared with the United States.

Authors:  Inhye Cho; Euna Han
Journal:  Int J Environ Res Public Health       Date:  2022-03-01       Impact factor: 3.390
  6 in total

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