我国儿童用药超90%非儿童专用药

Core Viewpoint - The article emphasizes the growing focus on pediatric drug development in China, driven by regulatory incentives and the need to address unmet medical needs for children [3][5]. Group 1: Current State of Pediatric Drug Development - In the first five months of the year, China approved 57 pediatric drugs, significantly surpassing the previous year's figures, yet pediatric drugs still represent a small fraction of total drug approvals [3]. - Over 90% of pediatric medications are not specifically designed for children, with only about 60 out of over 3,500 approved chemical drug formulations being pediatric-specific [5][6]. - The pediatric drug supply system faces critical issues such as drug shortages, lack of evidence-based clinical use, and irrational clinical applications [5]. Group 2: Regulatory Support and Guidelines - The National Medical Products Administration (NMPA) has issued guidelines to encourage the development of modified new drugs for pediatric use, focusing on improving safety, efficacy, and adherence [3][6]. - The guidelines specify that pediatric drug development should prioritize the protection of children's rights and reduce unnecessary repetitive studies [7][11]. - The NMPA encourages the use of real-world evidence and extrapolation from adult data to address recruitment challenges in pediatric clinical trials [11][12][13]. Group 3: Challenges in Pediatric Drug Development - The development of pediatric drugs is complicated by difficulties in recruiting child participants for clinical trials, ethical considerations, high costs, and lengthy timelines [10]. - The NMPA emphasizes the importance of ensuring participant safety in pediatric clinical trials, advocating for the use of existing research evidence to minimize unnecessary studies [11]. - Ethical constraints often lead to reliance on adult data for pediatric drug trials, which may not accurately predict adverse reactions specific to children [12]. Group 4: Importance of Modified New Drugs - Modified new drugs are crucial for children due to their unique physiological characteristics and metabolic differences from adults, offering a lower-cost and shorter development cycle compared to innovative drugs [6][7]. - The NMPA's guidelines highlight the need for drug formulations that are suitable for children, including considerations for dosage, taste, and ease of administration [6][8].