Regulatory Science of Medical Products

Regulatory Science of Medical Products

Published by Society for Regulatory Science of Medical Products

322 registered articles
(updated on January 05, 2026)

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

JOURNAL PEER REVIEWED RESTRICTED ACCESS

2025 Volume 15 Issue 3

Consideration on the Estimation of Efficacy and Study Design for Full Approval Under the Conditional and Time-limited Approval System Kohei UEMURA
Regulatory Aspects of Regenerative Medical Products in Japan: The PMDA Perspective Yoshiaki MARUYAMA, Junichi ASANO, Yasuhiro KISHIOKA
Initiatives to Publish Review Concepts Through Early Consideration of Pharmaceuticals and Medical Devices Agency (PMDA) (Part 2) Akiko OGATA, Daisuke IWATA, Toshiki SUGITA, Yuki ANDO, Yuya SUZUKI, Jihei NISHIMURA, Mahiro EGASHIRA, Shingo WATANABE
Discussion Related to Approval Document and Regulatory Actions for Changes Based on the Results of the Third Survey “the Questionnaire Survey on Actual Situation of Established Conditions, Regulatory Actions Required for Changes and GMP Inspection” Kozue SHIMIZUME, Yoshio NAKAYAMA, Sonoko YAMAUCHI, Masatsugu KOBAYASHI, Akinobu NAKANISHI, Maki MASUYAMA, Yasuyo OZAKI, Yukihiro TARUI, Makoto FUJIKAWA, Koji NAKAMURA, Yuji KASHITANI

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Most viewed articles (December 2025)

1

Comparison of Emergency Contraceptive Pill Regulations in Other Highly Developed Countries and Policy Recommendations for the Deregulation in Japan

Released on J-STAGE: January 31, 2024 | Volume 14 Issue 1 Pages 65-80

Carmen SAITO, Eriko KOBAYASHI

Views: 1,297
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Challenges of Instituting a Prescription Refill System in Japan

Released on J-STAGE: May 31, 2019 | Volume 9 Issue 2 Pages 69-78

Yuto AKABA, Yuki NOJO, Hiroko SAKURAI, Koichi MASUYAMA

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Food-effect Studies in New Drug Development: Considerations on Study Designs Based on an Analysis of Recent New Drug Applications in Japan

Released on J-STAGE: May 31, 2022 | Volume 12 Issue 2 Pages 125-141

Chisato NISHIDA, Akira OKADA, Naomi NAGAI

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International Comparison of Reporting Systems for Medical Device Malfunctions

Released on J-STAGE: September 30, 2024 | Volume 14 Issue 3 Pages 293-306

Koko AKAISHI, Tomomi SATOMI, Hideki MAEDA

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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

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