Abstract
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.
This is a preview of subscription content, access via your institution
Relevant articles
Open Access articles citing this article.
-
Platform trial for off-label oncology drugs using comprehensive genomic profiling under the universal public healthcare system: the BELIEVE trial
International Journal of Clinical Oncology Open Access 19 December 2023
-
A Survey of Industry Perceptions of Facilitated Regulatory Pathways in Drug Development in Australia
Pharmaceutical Medicine Open Access 27 June 2023
-
Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation
Therapeutic Innovation & Regulatory Science Open Access 17 November 2021
Access options
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Buy this article
- Purchase on Springer Link
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
References
Fujiwara, Y. & Kobayashi, K. Oncology drug clinical development and approval in Japan: the role of the pharmaceuticals and medical devices evaluation center (PMDEC). Crit. Rev. Oncol. Hematol. 42, 145–155 (2002).
Kagayama, K. & Ono, S. Actual performance of Japanese clinical development and regulatory review (2000-2014). Research Paper Series No. 68 (November 2015), Office of Pharmaceutical Industry Research, The Japan Pharmaceutical Manufacturers Association (in Japanese) http://www.jpma.or.jp/opir/research/rs_068/article_068.html (2015)
Fujiwara, Y., Yonemori, K., Shibata, T., Okita, N. & Ushirozawa, N. Japanese universal health care faces a crisis in cancer treatment. Lancet Oncol. 16, 251–252 (2015).
Acknowledgements
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.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
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)
Related links
Related links
FURTHER INFORMATION
Past decisions. Headquarters for Japanese Economic Recovery, Office of the Prime Minister
Rights and permissions
About this article
Cite this article
Fujiwara, Y. Evolution of frameworks for expediting access to new drugs in Japan. Nat Rev Drug Discov 15, 293–294 (2016). https://doi.org/10.1038/nrd.2016.68
Published:
Issue Date:
DOI: https://doi.org/10.1038/nrd.2016.68
