China Unveils Fifth List of Pediatric Drugs Promoting R&D
On September 9, China’s National Health Commission (NHC), Ministry of Industry and Information Technology (MIIT), National Healthcare Security Administration (NHSA), and National Medical Products Administration (NMPA) jointly released the Fifth List of Pediatric Drugs Encouraged for Research and Development (R&D) and Marketing Authorization, featuring a total of 15 medications.
This list focuses on drugs for young children and emergency situations, prioritizing those that tackle significant clinical challenges. It includes a variety of pediatric-friendly formulations and dosages, along with medications for rare diseases.
| No. | Name (CN) | Name (EN) | Dosage Form | Strength |
|---|---|---|---|---|
| 1 | 阿尼芬净 | anidulafungin | Injection | 0.1g; 0.05g |
| 2 | 柯拉特龙 | clascoterone | Cream | 1% |
| 3 | 头孢罗膦 | ceftaroline fosamil | Injection | 0.4g |
| 4 | 艾伐卡托 | ivacaftor | Granule | 25mg; 50mg; 75mg |
| 5 | 阿托伐他汀 | atorvastatin | Suspension | 5ml:20mg |
| 6 | 达比加群酯 | dabigatran etexilate | Pellet | 0.11g; 0.15g; 0.02g; 0.03g; 0.04g; 0.05g |
| 7 | 索利那新 | solifenacin | Suspension | 1ml:1mg |
| 8 | 托吡酯 | topiramate | Oral solution | 1ml:25mg |
| 9 | 托法替布 | tofacitinib | Oral solution | 1ml:1mg |
| 10 | 伊伐雷定 | ivabradine | Oral solution | 5ml:5mg |
| 11 | 氨曲南 | aztreonam | Inhalation solution | 75mg |
| 12 | 谷卡匹酶 | glucarpidase | Injection | 1000IU |
| 13 | 舒噻美 | sultiame | Oral suspension | 20mg/ml |
| 14 | 卡拉西珠单抗 | caplacizumab | Injection | 10mg |
| 15 | 瑞利珠单抗 | ravulizumab | Injection | 30ml:0.3g; 3ml:0.3g; 11ml:1.1g |
The NHC has indicated that it will prioritize the review and approval of the pediatric drugs listed and may include qualifying drugs in the National Essential Drug Catalog or the National Reimbursement Drug List (NRDL).
Reference link: Source
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