Why Japan for Drug Development　Vol.2 Taking the Next Steps with Your Drug in Japan

Why It Matters

The streamlined Japanese regulatory pathway and new DC office lower barriers for foreign innovators, helping to close the drug‑lag and expand market access for high‑need therapies.

Key Takeaways

• Japan ranks third globally in pharma market size.
• PMDA offers transparent, predictable review timelines and fast price listing.
• New PMDA Washington DC office facilitates direct US‑Japan regulatory dialogue.
• Japanese phase‑I trials often unnecessary if safety data are acceptable.
• Conditional approval rules are being revised to reduce drug lag.

Summary

The webinar, co‑hosted by NIK Biotechnology and sponsored by Nexera, focused on the latest PMDA initiatives that make Japan an increasingly attractive market for drug developers. Speakers highlighted Japan’s position as the world’s third‑largest pharmaceutical market, the transparency of PMDA’s review schedules, and the rapid, standardized drug‑price listing that follows approval. Key policy updates included the 2023 administrative notification stating that a dedicated Japanese phase‑I study is not required when safety and tolerability can be demonstrated from overseas data, and the allowance for approval based solely on pivotal foreign trials for orphan or high‑need therapies. PMDA also announced revisions to its conditional‑approval framework and an extension of re‑examination periods for pediatric and rare‑disease drugs to curb the historic drug‑lag. Dr. Yasu Fujiwara emphasized the market’s size and predictability, while Dr. Akiho Ishiguro explained the new Washington DC office’s role in providing English‑language consultation and direct liaison with the US FDA and venture firms. Early‑consideration guidance documents, such as those on externally controlled trials, illustrate PMDA’s push toward more flexible, science‑based evaluation pathways. For multinational sponsors, these developments mean faster entry timelines, clearer regulatory expectations, and a dedicated channel for real‑time dialogue with Japanese authorities, potentially accelerating patient access to innovative therapies in Japan.

Original Description

This Video, which is authorized by the ENDPOINTS News, was published on the ENDPOINTS Events on May 21st, 2025.

・The information in this video is based on the laws, regulations, and notifications in effect as of the date the ENDPOINTS Events was held.

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.

Dr. Yasuhiro Fujiwara (Chief Executive, PMDA)

Dr. Akihiro Ishiguro (Head of the PMDA Washington D.C. Office, PMDA)

Moderator: Aya Kubota (Editor-in-Chief, Nikkei Biotechnology & Buisiness)