Literature DB >> 27139984

Evolution of frameworks for expediting access to new drugs in Japan.

Yasuhiro Fujiwara1.   

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.

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Year:  2016        PMID： 27139984     DOI： 10.1038/nrd.2016.68

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN： 1474-1776            Impact factor:   84.694


  2 in total

Review 1.  Oncology drug clinical development and approval in Japan: the role of the pharmaceuticals and medical devices evaluation center (PMDEC).

Authors:  Yasuhiro Fujiwara; Ken Kobayashi
Journal:  Crit Rev Oncol Hematol       Date:  2002-05       Impact factor: 6.312

2.  Japanese universal health care faces a crisis in cancer treatment.

Authors:  Yasuhiro Fujiwara; Kan Yonemori; Taro Shibata; Natsuko Okita; Nobuko Ushirozawa
Journal:  Lancet Oncol       Date:  2015-03       Impact factor: 41.316
  2 in total
  10 in total

Review 1.  Implementation of "clinical sequencing" in cancer genome medicine in Japan.

Authors:  Takashi Kohno
Journal:  Cancer Sci       Date:  2018-02-02       Impact factor: 6.716

2.  Advanced Medical Care Program for the Rapid Introduction of Healthcare Technologies to the National Health Insurance System in Japan.

Authors:  Keiko Ueda; Shoji Sanada; Naoto Uemura
Journal:  Clin Transl Sci       Date:  2020-02-27       Impact factor: 4.689

3.  Feasibility and utility of a panel testing for 114 cancer-associated genes in a clinical setting: A hospital-based study.

Authors:  Kuniko Sunami; Hitoshi Ichikawa; Takashi Kubo; Mamoru Kato; Yutaka Fujiwara; Akihiko Shimomura; Takafumi Koyama; Hiroki Kakishima; Mayuko Kitami; Hiromichi Matsushita; Eisaku Furukawa; Daichi Narushima; Momoko Nagai; Hirokazu Taniguchi; Noriko Motoi; Shigeki Sekine; Akiko Maeshima; Taisuke Mori; Reiko Watanabe; Masayuki Yoshida; Akihiko Yoshida; Hiroshi Yoshida; Kaishi Satomi; Aoi Sukeda; Taiki Hashimoto; Toshio Shimizu; Satoru Iwasa; Kan Yonemori; Ken Kato; Chigusa Morizane; Chitose Ogawa; Noriko Tanabe; Kokichi Sugano; Nobuyoshi Hiraoka; Kenji Tamura; Teruhiko Yoshida; Yasuhiro Fujiwara; Atsushi Ochiai; Noboru Yamamoto; Takashi Kohno
Journal:  Cancer Sci       Date:  2019-04-02       Impact factor: 6.716

4.  Clinically Integrated Molecular Diagnostics in Adenoid Cystic Carcinoma.

Authors:  Julia Thierauf; Nisha Ramamurthy; Vickie Y Jo; Hayley Robinson; Ryan P Frazier; Jonathan Gonzalez; Maciej Pacula; Enrique Dominguez Meneses; Vania Nose; Valentina Nardi; Dora Dias-Santagata; Long P Le; Derrick T Lin; William C Faquin; Lori J Wirth; Jochen Hess; A John Iafrate; Jochen K Lennerz
Journal:  Oncologist       Date:  2019-03-29

5.  Application of the New Process for Unapproved Drug Use: Dilemma of Universal Health Care Coverage in Japan.

Authors:  Satoshi Nishiwaki; Yuichi Ando
Journal:  J Glob Oncol       Date:  2019-11

6.  Global Development of Anticancer Therapies for Rare Cancers, Pediatric Cancers, and Molecular Subtypes of Common Cancers.

Authors:  H Kim Lyerly; Jun Ren; Renzo Canetta; Gi Hyun Kim; Sumimasa Nagai; Tomohiro Yamaguchi; Ken Hatogai; Hiroshi Katayama; Silvy Da Rocha Dias; Daniel McManus; Kathy Soltys; Zhimin Yang; Olufumilayo Olopade; Nancy Goodman; Greg Reaman; Thomas Gross
Journal:  J Glob Oncol       Date:  2018-12

Review 7.  Emerging PD-1/PD-L1 targeting immunotherapy in non-small cell lung cancer: Current status and future perspective in Japan, US, EU, and China.

Authors:  Takaaki Mizuno; Yuki Katsuya; Jun Sato; Takafumi Koyama; Toshio Shimizu; Noboru Yamamoto
Journal:  Front Oncol       Date:  2022-08-26       Impact factor: 5.738

Review 8.  Bringing Advanced Therapies for Parkinson's Disease to the Clinic: An Analysis of Ethical Issues.

Authors:  Kristina Hug
Journal:  J Parkinsons Dis       Date:  2021       Impact factor: 5.568

9.  Distribution of erlotinib in rash and normal skin in cancer patients receiving erlotinib visualized by matrix assisted laser desorption/ionization mass spectrometry imaging.

Authors:  Meiko Nishimura; Mitsuhiro Hayashi; Yu Mizutani; Kei Takenaka; Yoshinori Imamura; Naoko Chayahara; Masanori Toyoda; Naomi Kiyota; Toru Mukohara; Hiroaki Aikawa; Yasuhiro Fujiwara; Akinobu Hamada; Hironobu Minami
Journal:  Oncotarget       Date:  2018-04-06

10.  Compassionate use and hospital exemption for regenerative medicine: Something wrong to apply the program for patients in a real world.

Authors:  Kazuo Yano; Masayuki Yamato
Journal:  Regen Ther       Date:  2018-04-07       Impact factor: 3.419
  10 in total

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