Drug Evaluation Committee March 25, 2024 "Symposium on Pediatric Drug Development - Toward a New Era of Pediatric Drug Development" to be held on March 25, 2024
April 30, 2024
Materials for the "Symposium on Pediatric Drug Development - Toward a New Era of Pediatric Drug Development" to be held on March 25, 2024 are now available.
At this symposium, the latest information from the regulatory authorities, academia, and medical institutions, as well as the survey conducted by the Clinical Evaluation Subcommittee, were shared regarding the current status of pediatric drug development in Japan and efforts to promote development.
The "Study Group on the Drug Regulatory System to Enhance Drug Discovery and Ensure Stable Supply," held in FY2023, examined the We hope you will deepen your understanding of the current environment surrounding pediatric drug development and issues to be addressed to promote pediatric drug development in the future, including measures to promote pediatric drug development as discussed in the "Study Group on the Regulatory Framework for Enhancing Drug Discovery Capability and Ensuring Stable Supply" held in FY2023.
- 0_Program
- 1-1_Survey and Research for the Promotion of Drug Development for Pediatric Oncology and Rare or Intractable Diseases in Children", FY2022 MHLW Special Research Project -Current Situation and Issues in Pediatric Drug Development
- 1-2_Issues and Efforts in Drug Development for Pediatric Oncology
- 1-3_Outline of the Study Group on Regulation of Pharmaceutical Affairs to Enhance Drug Discovery Capability and Ensure Stable Supply, etc. and Efforts by the Ministry of Health, Labour and Welfare
- 2-1_Report on the recent development and clinical data package for approved pediatric drugs
- 2-2_Examples of Extrapolation Strategies and Utilization of Existing Data for Recently Approved Pediatric Drugs
- 2-3_Initiatives for Information Generation in Clinical Practice
- 3-1_ Challenges in case accumulation in pediatric clinical trials from the standpoint of companies
- 3-2_ Challenges in conducting pediatric clinical trials from the perspective of CRCs and efforts to improve case accumulation
- 3-3_ Efforts to Promote Pediatric Drug Development
- 3-4_ Efforts by the Ministry of Health, Labour and Welfare to Promote Pediatric Drug Development