Objective: The current issues in children’s medication are prominent in China

characterized by a limited variety of suitable drugs

a lack of appropriate dosage forms and specifications for children

and off-label drug use. In recent years

drug regulatory authorities have issued multiple support policies and guiding principles for pediatric drug development in China

leading to an increasing enthusiasm for research and development among enterprises. This article reviews the relevant supporting policies for domestic pediatric drug development

attempts to propose directions for the initiation of pediatric drug projects from the perspective of enterprises

and analyzes the issues that need attention in research and development initiation.