Research on the safety monitoring effects of pediatric drug data protection regime in the US / 中国药学杂志

ABSTRACT

OBJECTIVE: To analyze the safety monitoring effects of pediatric drug data protection regime in the US and provide the suggestions to improve the safety of pediatric drugs in China. METHODS: Theoretical analysis and case study of Duragesic (Fentanyl transdermal patch). RESULTS: The pediatric drug data protection regime promoted safety monitoring effectively. CONCLUSION: II is necessary to establish pediatric drug data protection system in China by referring to the experience of US, to enhance the lilecycle risk management and the responsibilities of enterprises, so as to improve the safety of pediatric drug.