Regulatory Science of Medical Products

Regulatory Science of Medical Products

Published by Society for Regulatory Science of Medical Products

322 registered articles
(updated on November 08, 2025)

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

JOURNAL PEER REVIEWED RESTRICTED ACCESS

2025 Volume 15 Issue 3

The Questionnaire Survey on the Actual Situation of Development Projects in Japan Among the Japan Pharmaceutical Manufacturers Association’s Regulatory Affairs Committee Member Companies―Discussion on the Status of Rare Disease and Pediatric Development in Japan Among the Global Development Products― Yuki MINAMIDE, Saiko MURATA, Miyoko ONODA, Kyohei SHINTAKU, Yoshiyuki HATTORI, Sayaka IIYAMA, Miho KAMEYA, Kazumi KAWAHATA, Koichi NAGAO, Tomohiro NAKATSU, Yuki NISHIOKA, Maki OBARA, Kazumi OHFUJI, Chiharu ONOUE, Naohiro SAITO, Emiko SEKI, Noriko TAKASHIMA, Yoshiaki TOYOMORI, Chikako YAGI, Miho YAMAMOTO, Hironori TAKAYAMA, Yuji KASHITANI
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
Current Situation of Conditional and Time-Limited Approval of Regenerative Medical Products in Japan Toshio UEMURA
Consideration on the Estimation of Efficacy and Study Design for Full Approval Under the Conditional and Time-limited Approval System Kohei UEMURA

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

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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

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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

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