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OBJECTIVE To identify the current status of pediatric traditional Chinese medicine (TCM) new drug development in China using registration and approval data, and to provide references for improving the pediatric drug regulatory system. METHODS A total of 468 pediatric TCM new drug registration applications accepted by the China National Medical Products Administration from 2002 to 2024 were collected. Registration profiles, review timelines, registration categories, and product distribution characteristics were analyzed in conjunction with policy backgrounds and literature. RESULTS The total number of registration applications initially increased and then decreased, peaking during the implementation of the 2002 and 2005 editions of the Drug Registration Regulation, followed by a sharp decline after the 2007 edition. The review timelines were progressively shortened, with a notable improvement in approval efficiency under the 2020 edition. Modified new drugs consistently dominated registration categories, while the proportion of TCM compound formulations gradually increased. Products were concentrated in respiratory and digestive system therapies, primarily formulated as granules and tablets. Development in other disease areas and pediatric-friendly dosage forms remained insufficient. CONCLUSION Pediatric TCM development in China predominantly focuses on modified new drugs, with issues of product homogeneity and limited innovation momentum. Recommendations include optimizing priority review mechanisms, establishing specialized pediatric TCM research and development guidelines, strengthening clinical demand-driven innovation, and promoting high-quality pediatric TCM formulations.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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