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March 9, 2026
Approximately 5 minutes
Q&A on Extending Re-Examination Periods for Pediatric Drug Development in Japan
1. Publication Details
Issued November 26, 2020 (provisional translation as of May 2024). From Pharmaceutical Evaluation Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare. https://www.pmda.go.jp/files/000268678.pdf
2. Background
The Q&A summarizes questions and answers for Note 1-4 of the Notification by Director on handling re-examination periods, focusing on extensions associated with pediatric dosage and administration development. It references “Handling of Re-Examination Period” (PSEHB/PED Notification dated August 31, 2020). https://www.pmda.go.jp/files/000268678.pdf
3. Purpose
To provide clarification on the extension of re-examination periods for drugs involving pediatric development, ensuring related parties are informed through prefectural health departments. https://www.pmda.go.jp/files/000268678.pdf
4. Target Products
Applies to prescription drugs requiring extension of re-examination periods in association with development of pediatric dosage and administration. https://www.pmda.go.jp/files/000268678.pdf
5. Eligibility Types
Eligibility includes cases where pediatric development is deemed necessary, with explanations in CTD Module 1.5, and prompt initiation of planned clinical studies post-approval. https://www.pmda.go.jp/files/000268678.pdf
6. Consultation Pathways
Not specified, but inquiries should be directed to the Pharmaceutical Evaluation Division for implementation details. https://www.pmda.go.jp/files/000268678.pdf
7. Approval Application and Review Expectations
In CTD Module 1.5, explain the necessity of pediatric development and outline the plan, including clinical study timelines. Reviews will consider appropriateness of submissions and study starts. https://www.pmda.go.jp/files/000268678.pdf
8. Procedure After Approval (Post-marketing Obligations)
Planned clinical studies should start without delay, typically within 2 years post-approval via clinical trial notification submission, subject to appropriate review. https://www.pmda.go.jp/files/000268678.pdf
9. Practical Considerations
The Q&A addresses specific descriptions in Note 1-4, such as submission by review end and prompt study start, providing examples and flexibility in reviews. https://www.pmda.go.jp/files/000268678.pdf
10. Effective Date
November 26, 2020. https://www.pmda.go.jp/files/000268678.pdf
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