Legislative evolution of pediatric drug regulation in United States and its implications for China
There are similarities between the regulatory history of pediatric medicines in the United States and dilemma of the pediatric medicines regulation faced by China at present.Analyze the development history and current situation of pediatric medicines administration regulations in the United States can provide reference for improving pediatric drug administration policies and related regulations in China.In order to solve the problem of"Therapeutic Orphans",promote pediatric clinical studies,and ensure that drug labeling contain adequate information on pediatric use,the United States has gradually established a policy system that combines"economic incentives"and"mandatory requirement"after decades of exploration.Based on the advanced administration experience of pediatric medicines in the United States and the problems of China's pediatric mediacines regulation at this stage,it is recommended that,first of all,administration authorities should introduce mandatory requirements to administration system of pediatric medicines,and provide powerful economic incentives for pediatric product development;Secondly,set up regulatory tools similar to pediatric study plan,and strengthen the input of regulatory resourses.
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