Evolution of frameworks for expediting access to new drugs in Japan

Author:

Fujiwara Yasuhiro

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmacology,General Medicine

Reference3 articles.

1. 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).

2. 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)

3. 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).

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