Original ResearchVol. 27, Issue 2 • pp. 145-158DOI: 10.1007/s40272-024-00567-8
Pediatric Drug Development in China: Current Status, Challenges, and Future Directions
Authors: Y. Zhang, L. Wang, H. Li, et al.
Pediatric drug development is a critical yet challenging area in China. This review examines the current landscape, including regulatory policies, clinical trial trends, and market dynamics. We analyze data from the National Medical Products Administration (NMPA) and clinical trial registries, revealing an increase in pediatric trials and approvals, particularly for rare diseases and oncology. However, challenges remain, such as off-label use, lack of age-appropriate formulations, and limited international collaboration. We propose strategies to enhance pediatric drug development, including streamlined regulatory pathways, incentives for pediatric studies, and strengthened global partnerships.
Graphical Abstract