This page previously did not announce that following the “Japanese-language Distribution of China Information” in “Drug R&D Expert” (69 issues published) from July 2021 to March 2024 (2 years and 8 months), we are now conducting the “Chinese-language Distribution of Japan Information” (32 issues planned) under the title “Overseas Expansion into Japan” from February to December 2025 (11 months).
This year’s Chinese edition of “Overseas Expansion into Japan” divides content into three series with assigned authorship: Series A covers clinical development, Series B covers regulatory affairs, and Series C covers interviews and conferences, each disseminating the latest information from Japan.
★Series A: History of clinical trials in Japan, Japan’s unique clinical trial information registration website, differences between ICH-GCP and J-GCP, Japan’s common ICF template, Single IRB, benchmark-based clinical trial cost calculation using Fair Market Value, Decentralized Clinical Trial (DCT), etc.
★Series B: Japan’s regulatory authorities, Japan’s pharmaceutical regulations, PMDA consultations, Japan’s orphan drug designation system, Japan’s Clinical Trial Notification (CTN) system, Japan’s application categories for NDA, application preparation for NDA in Japan, application and review processes at MHLW/PMDA, etc.
★Series C: PMDA Executive Officers Yoshiaki Uyama and Naoyuki Yasuda, National Cancer Center Hospital (NCCH) International Clinical Development Department Head Kenichi Nakamura, JPMA Drug Evaluation Committee Chair Shigeru Nakaji, DIA China Annual Meeting 2025, DIA Global Forum, DIA Japan Annual Meeting 2025, etc.
For your reference, regarding the latest issue of “Overseas Expansion into Japan” (Issue 24, Series C – Part 7: DIA Japan Annual Meeting 2025 Report) published on October 27, 2025 (in Chinese), links to the PharmaDJ Website and WeChat are provided below. We would appreciate it if you could take a look.
Incidentally, back issues prior to Issue 24 can be found at the bottom of the page when scrolling through the Issue 24.
■Issue 24 (Series C – Part 7): DIA Japan Annual Meeting 2025 Report published on October 27, 2025 (in Chinese)
PharmaDJ Website
https://www.pharmadj.com/ssr/article/1982446196058296322
PharmaDJ WeChat
