OBJECTIVE To analyze the current situation and problems of the accessibility of child-specific drugs for respiratory system disease in China, so as to provide reference for making policy.

METHODS Based on the standard code of national drug code, the approval documents, varieties and dosage forms of the marketed child-specific drugs for respiratory system disease in China were systematically reviewed by means of the user manuals. The marketing situation of respiratory drugs recommended by EMLc-8th in China was compared and analyzed to obtain their availability. Based on the price data of drug bidding information in Menet, WHO/HAI affordability measurement method was used to analyze the affordability. The accessibility was comprehensively assessed from the above two dimensions.

RESULTS In terms of availability, the number of marketing approvals and varieties of child-special drugs for respiratory system disease in China was relatively rich, but there was still a big gap compared with the drugs shared by adults and children. It had a certain abundance of dosage forms, but there were deficiencies in the appropriate and innovative dosage forms for young children. The drugs recommended by EMLc-8th in the same treatment field were well marketed in China, but the related drugs were not marketed in the form of child-specific drugs. In terms of affordability, most of therapeutic use child-specific drugs for respiratory system disease had good affordability, but about 45% of the drugs still had affordability problems in different degrees, and the affordability statistics of children’s specialized vaccines for respiratory system prevention were poor.

CONCLUSION The accessibility of child-specific drugs with respiratory system disease in China is generally acceptable, but there are still some problems. In order to achieve the goal of accessibility optimization, it should improve the whole life cycle incentive policy system for child-specific drug using, and actively explore the post marketing incentive based on the circulation and use.