Including Japan in global trials: New PMDA rules and DC office support

Nikkei Biotech’s Aya Kubota will interview Dr. Yasuhiro Fujiwara, Chief Executive of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and Dr. Akihiro Ishiguro, Head of the PMDA Washington D.C. Office, about the agency’s updated guidance that allows Japan to participate in certain multinational studies without a separate Phase 1 in Japanese volunteers when predefined conditions are satisfied. The speakers will explain the specific data requirements behind this policy change and describe how sponsors can use the new Washington office to schedule consultations, request scientific advice, and stay informed throughout the submission process.

To view slides from this panel, click here.

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Launching a specialty medicine in Japan successfully

The importance of specialty care in Japan is rapidly increasing, driven by evolving patient needs and a changing healthcare landscape. However, success in this field requires unique expertise, as commercial strategies and operational know-how often differ significantly from those in the US and EU. In this session, we will explore what it takes to successfully launch specialty medicines in Japan, sharing practical insights and a case study to highlight the key factors and approaches that can make a difference.

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The Japanese market from a drug maker's perspective

Explore the Japanese pharmaceutical opportunity through the eyes of those who’ve done it. Our panel features a biotech leader overseeing cancer drug development in Japan and a senior executive from Japan’s drug R&D association. You’ll learn about the market’s strategic positioning, regulatory pathways, and pricing mechanisms that drive commercial success.

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