Literature DB >> 20856242

PMDA's challenge to accelerate clinical development and review of new drugs in Japan.

K Ichimaru1, S Toyoshima, Y Uyama.   

Abstract

In recent years, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has conducted several projects to shorten drug development and review times in Japan to resolve the "drug lag." Key to achieving this goal is greater involvement by the PMDA in drug development through enhancement of scientific consultation and improvement of the review process by reinforcing the operational system, including hiring more reviewers. We discuss here the current projects of the PMDA as well as future challenges.

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Year:  2010        PMID： 20856242     DOI： 10.1038/clpt.2010.190

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


  4 in total

Review 1.  Pharmacogenetics and cardiovascular disease--implications for personalized medicine.

Authors:  Julie A Johnson; Larisa H Cavallari
Journal:  Pharmacol Rev       Date:  2013-05-17       Impact factor: 25.468

2.  An international survey of physicians regarding clinical trials: a comparison between Kyoto University Hospital and Seoul National University Hospital.

Authors:  Toshiko Ito-Ihara; Jeong-Hwa Hong; Ock-Joo Kim; Eriko Sumi; Soo-Youn Kim; Shiro Tanaka; Keiichi Narita; Taichi Hatta; Eun-Kyung Choi; Kyu-Jin Choi; Takuya Miyagawa; Manabu Minami; Toshinori Murayama; Masayuki Yokode
Journal:  BMC Med Res Methodol       Date:  2013-10-25       Impact factor: 4.615

3.  Application of Physiologically Based Pharmacokinetic Modeling to Predict Pharmacokinetics in Healthy Japanese Subjects.

Authors:  Yuki Matsumoto; Tamara Cabalu; Punam Sandhu; Georgy Hartmann; Takashi Iwasa; Hiroyuki Yoshitsugu; Christopher Gibson; Naoto Uemura
Journal:  Clin Pharmacol Ther       Date:  2018-12-04       Impact factor: 6.875

4.  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
  4 in total

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