Li Yan, Li Sanni, Zhang Meng, et al. Investigation on Current Status of Neonatal Medication and Drug Lists That Encourage Research and Development[J]. 2023,29(11):1-5.
Li Yan, Li Sanni, Zhang Meng, et al. Investigation on Current Status of Neonatal Medication and Drug Lists That Encourage Research and Development[J]. 2023,29(11):1-5. DOI: 10. 13407/ j. cnki. jpp. 1672-108X. 2023. 11. 001.
Objective: To investigate drugs widely used abroad but not yet on the market in China
encourage domestic enterprises to develop or import drugs with different varieties or dosage forms
and effectively supplement the treatment drugs for neonatal diseases in China. Methods: Based on Neofax 2020 US Neonatal Medication Guidelines and the first-line neonatal treatment drug list of 22 domestic hospitals
the Chinese Pediatric Drug Database and World Health Organization (WHO) essential drugs were queried. According to evaluation form of suitable dosage forms for children issued by the European Union
it was recommended to develop varieties and dosage forms suitable for infants
neonates and premature infants. This list was analyzed according to the third edition of list of children’s drugs that encourage research and development issued by the National Health Commission. Results: A total of 248 drugs with different routes of administration were investigated in the Chinese Pediatric Drug Database
including 22 varieties recommended by Neofax 2020 for first- line use in China. The investigation found that there were 10 generic names and 11 routes of administration of drugs that need to be introduced or developed urgently in China. And there were 31 generic names
44 routes of administration and 56 dosage forms of drugs with this variety without suitable dosage forms in China. Conclusion: The list of drugs to encourage research and development derived from this study is a useful exploration and attempt given at the level of drug production and dosage form specifications
which can provide some assistance to the research
development and production of neonatal medication in China.
关键词
新生儿剂型鼓励研发申报儿童药品清单中国儿童用药数据库
Keywords
neonatedosage formlist of children’s drugs that encourage research and developmentChinese Pediatric Drug Database