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Paediatric Drug Development in Japan: Current Status and Future Challenges.
Rieko Inagaki1, Mamoru Narukawa2
1Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, Tokyo, Japan. inagakirieko@gmail.com.
Therapeutic Innovation & Regulatory Science
|September 27, 2024
Summary
Measures promoting pediatric drug development in Japan show success, with increasing approvals. However, wider use of adult data extrapolation is needed for more pediatric drug indications.
Area of Science:
- Pharmacology
- Pediatric Drug Development
- Regulatory Science
Background:
- Limited pediatric drug labeling globally before 2000.
- Regulatory initiatives in the US and Europe, and ICH-E11 guideline, increased pediatric drug labels.
- Japan has implemented measures to foster pediatric drug development.
Purpose of the Study:
- To evaluate the success of Japanese initiatives promoting pediatric drug development.
- To analyze trends in pediatric drug approvals and development characteristics in Japan.
Main Methods:
- Examined new drug approvals for pediatric indications in Japan (2006-2023).
- Assessed clinical data packages, drug characteristics, and pediatric clinical trials.
- Quantified the percentage of adult data extrapolation in recent pediatric drug development (2015-2023).
Main Results:
- Paediatric drug approvals show an increasing trend (2006-2023).
- Proportion of paediatric indications rose to 48% in 2023.
- Simultaneous adult/pediatric development was 59% (2015-2023), but adult data extrapolation was limited (11.2%).
Conclusions:
- Upward trend in paediatric drug approvals suggests promotional measures are effective in Japan.
- Limited number of drugs with additional pediatric indications remains a concern.
- Scientific justification for adult data extrapolation should be considered for development strategies.
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