关键词: font-size:medium, ">儿童专用药；国产药品；剂型；适应证

Abstract: Objective： To analyze the approval of children′s drug use in China and explore its basic attributes to provide reference for guiding the development of children′s drug use and clinical drug use. Methods： In this study， data mining was conducted based on the 2014—2019 effective approval data of domestic children′s drug use provided by the information center of the National Population Health Data Center， to explore the overall situation of domestic children′s drug use， to systematically analyze the dosage form and treatment field distribution of domestic children′s drug use， and to draw conclusions based on the comparative analysis of domestic and foreign policies. Results： At present， traditional Chinese medicine has a certain development potential in children′s only medicine. At present， tablets and granules are the most accepted and relatively mature dosage forms for children. The dosage forms without gastrointestinal administration have certain development potential in the only dosage forms for children. There are many chemical drugs developed in children′s clinical medication. Traditional Chinese medicine is concentrated in children′s common diseases. Traditional Chinese medicine for children has more potential and opportunity in the development of digestive system and antipyretic and analgesic drugs. Conclusion： On the premise of vigorously developing the development of children′s drug use， China should learn from the advanced experience of foreign countries， improve the basic catalogue of children′s drug use as soon as possible based on evidence， compile the authoritative guidelines for children′s drug use in China， and improve the safety system of children′s drug use.

Key words: font-size:medium, ">Children′s drug use； Domestic drug； Evidence-based medicine； Rational drug use