亚洲社会药学

Objective To study the current status and main problems of children’s drug in China by taking children’s essential and non-essential drugs as the research objects, and to analyze the causes and put forward countermeasures so as to provide reference for the subsequent formulation of children’s drug policies. Methods Through literature research and statistical description, the relevant data of drugs marketed before December 2021 in China were investigated, and the types, dosage forms, specifications and clinical use of children’s drugs were clarified. Results and Conclusion The species, dosage forms and specifications of drugs for children only are lacking, and the disease areas covered are relatively concentrated. essential drugs are missing in the description of children’s medications, and off-label medication is normal. Then, four suggestions are put forward in a targeted manner. Firstly, we should continue to improve the corresponding policies and encourage manufacturers to actively carry out the research and development of new drugs for children with suitable dosage forms. Secondly, we should strengthen the approval of products whose yield can meet clinical needs. Thirdly, clinical trials can be simplified for children’s off-label use of drugs that have been in clinical use for many years and no serious adverse reactions have been found. Fourthly, a children’s medication database should be built to promote enterprises to strengthen real-world data research and improve children’s medication instructions.