快速检索
年期检索
摘要： Objective To analyze the current status of pediatric drug development in China from the perspective of pediatric drug registration and clinical trials so as to provide a reference for its improvement. Methods The registration and clinical trials explicitly labeled as pediatric drugs were analyzed by using the Insight Database, National Medical Products Administration (NMPA), and other publicly available information. Results and Conclusion The number of applications for pediatric drug registration was 196, and 104 were for domestic drugs, accounting for 53.06%. The number of pediatric drugs included in the priority review was 116, and 70.18% have completed the review. However, the number of new pediatric drug marketing applications is still not optimistic. Only 5 applications for pediatric drug registration are accepted by Center for Drug Evaluation (CDE), accounting for 4.63%. There are difficulties in recruiting pediatric subjects in clinical trials, with 42.08% of completed recruitment projects. Besides, there are few institutions for drug clinical trials, the distribution of institutions and professional certification are uneven. Therefore, enterprises should be encouraged to carry out research and development of pediatric drugs from two aspects: improving the policy for pediatric drugs and strengthening the clinical management of pediatric drugs to guarantee their safe use.
