The Pharmaceuticals and Medical Devices Agency (PMDA) has released official guidance outlining the submission procedures for clinical trial plan notifications and related documents during the year-end and New Year holiday period. This annual notice ensures uninterrupted processing and compliance with Japan’s regulatory requirements for clinical research activities.
Key highlights include:
- Holiday Period: From December 27, 2025, to January 4, 2026, PMDA offices will observe the year-end break.
- Submission Deadlines:
- For 30-day study notifications, submissions are requested by December 3, 2025, to accommodate the review timeline.
- Submissions will resume on January 6, 2026.
- Other Notifications: Changes, completions, cancellations, and development withdrawals (excluding 30-day surveys) will be accepted until December 26, 2025, and reopen on January 5, 2026.
- Safety Reports: Annual clinical trial safety reports must be submitted by December 26, 2025.
- Planning Recommendations: Sponsors are advised to plan contract conclusion dates and submission schedules in advance to avoid delays during the closure period.
- Contact Information: The PMDA provides designated contact points for inquiries related to submission procedures and documentation requirements.
This guidance underscores PMDA’s proactive approach to maintaining regulatory continuity and supporting efficient clinical trial management in Japan.
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