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Evolution of frameworks for expediting access to new drugs in Japan


Japanese clinical research and regulatory frameworks have evolved considerably in the past two decades to reduce the delay in the introduction of new drugs in Japan compared with other major markets. However, recently introduced changes related to access to unapproved drugs might have the opposite effect and might not benefit all patients.

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The author would like to thank B. A. Chabner, F. Pignatti, C. Matsuda and H. Ozaki for their valuable insights during the development of this article.

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Correspondence to Yasuhiro Fujiwara.

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Competing interests

Y.F. has received a grant and a contract from the Ministry of Health, Labour and Welfare (MHLW), Japan, and a grant from the Japan Agency for Medical Research and Development between April 2013 and March 2016. He served on several committees or as a research program officer of the MHLW, Japan, the Ministry of Education, Culture, Sports, Science and Technology, Japan, and the Japan Agency for Medical Research and Development. He has received lecture fees from AstraZeneca KK, Eisai Co. Ltd, Sanofi-Aventis KK, Daichi Sankyo Co. Ltd, Chugai Pharmaceutical Co. Ltd, Eli Lilly Japan KK, Yakult Honsha Co. Ltd and NEC corporation between April 2013 and March 2016. He has received research grants from Taiho Pharmaceutical Co. Ltd, Takeda Pharmaceutical Co. Ltd, Takeda Bio Development Center Ltd, Chugai Pharmaceutical Co. Ltd, Eli Lilly Japan KK and Nippon Kayaku Co. Ltd between April 2013 and March 2016.

Supplementary information

Supplementary information S1 (figure)

Timeline of regulatory actions for expedited drug access in Japan, the European Union and the United States (PDF 136 kb)

Supplementary information S2 (table)

Recent regulatory systems for expedited drug access in Japan (PDF 117 kb)

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Past decisions. Headquarters for Japanese Economic Recovery, Office of the Prime Minister

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Fujiwara, Y. Evolution of frameworks for expediting access to new drugs in Japan. Nat Rev Drug Discov 15, 293–294 (2016).

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