Regulatory Science of Medical Products

Regulatory Science of Medical Products

Published by Society for Regulatory Science of Medical Products

314 registered articles
(updated on June 16, 2025)

Online ISSN : 2189-0447
Print ISSN : 2185-7113
ISSN-L : 2185-7113

JOURNAL PEER REVIEWED RESTRICTED ACCESS

2025 Volume 15 Issue 2

Assessment of the Eligibility for Drugs with High Medical Need in the “Evaluation Committee on Unapproved or Off-Label Drugs with High Medical Need” Nozomi OMURA, Saki AINO, Kazuhiro MATSUI, Mamoru NARUKAWA
AstraZeneca’s Initiatives for Prospective Harmonization Pilot Program for Drug Substance and Drug Product Monographs by the JP and USP Ryo KONDO
Simulation of the Economic Value of a Transferable Regulatory Privilege in Japan Kuni ITOH, Shingo KANO
Initiatives to Publish Review Concepts through Early Consideration of Pharmaceuticals and Medical Devices Agency (PMDA) Akiko OGATA, Hisanao IZUMI, Hideki HIRAOKA, Hiroyuki MURAKAMI, Yasuhisa IDENO, Takashi OGAWA, Ryosuke KATO, Yoshihiro MATSUDA, Hiroto INUZUKA

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Most viewed articles (May 2025)

1

Comparison of the Japanese Pharmacopoeia, United States Pharmacopeia, and European Pharmacopoeia : Consideration on Similarities and Differences on Constitution, General Notices, and Control of Impurities

Released on J-STAGE: May 31, 2018 | Volume 8 Issue 2 Pages 55-68

Maki MATSUHAMA, Chie MIZUMARU, Seiko MIYAZAKI

Views: 504
2

Regulatory Considerations of Conditional Approval for Balancing Pre-market and Post-market Evaluations to Achieve Early Patient Access to Medical Products in Japan

Released on J-STAGE: May 31, 2021 | Volume 11 Issue 2 Pages 93-110

Shunsuke MATSUSHITA, Keisuke TACHIBANA, Tetsuya KUSAKABE, Yasuo TSUTSUMI, Masuo KONDOH

Views: 236
3

Current Status and Trends of In Vivo Diagnostics

Released on J-STAGE: January 31, 2019 | Volume 9 Issue 1 Pages 5-15

Yoshinori TSUKUMO, Takayoshi SUZUKI, Mikihiko NAITO

Views: 186
4

Mesenchymal Stem Cell-based Therapy

Released on J-STAGE: May 31, 2018 | Volume 8 Issue 2 Pages 103-108

Akihiro UMEZAWA, Yuri TAKAHASHI

Views: 177
5

Basic Principles of Biological Safety Evaluation Required for Application for Approval to Japanese Market Medical Devices and Trends of Related ISO Standards

Released on J-STAGE: May 31, 2020 | Volume 10 Issue 2 Pages 47-54

Keisuke SAKAGUCHI

Views: 160

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