Investigation on Current Availability of Pediatric Drugs in China Based on National Drug Coding Database

OBJECTIVE To analyse current availability of pediatric drugs in China quantitatively and provide fundamental data support for optimizing the incentive policy.

METHODS Based on national drug coding database issued by National Medical Products Administration, the marketed drugs were classified into children's only drug, adult-children's drug, children's inferred drug and non-children's drug by consulting the drug instructions through the approval number. Taking children's only drug and adult-children's drug as the key subjects, this paper carried out statistics and analysis on the marketing status of pediatric drugs in China from the perspectives of approval, variety, dosage form, specification, distribution of treatment fields, enterprise and so on.

RESULTS Among the marketed drugs, there were 4 229 approvals for pediatric drugs and 44 112 approvals for adult-children's drugs, accounting for 2.99% and 31.19% respectively. children's only drug had 625 varieties, accounting for 18.83% of the total pediatric drug varieties. Analgesic, antipyretic, anti-inflammatory, anti-rheumatic and anti-gout drugs accounted for 55.71% of the total approvals for children's only drug(chemicals and biologics, excluding vaccines), and expectorant, antitussive and antiasthmatic agents accounted for 26.71% of total approvals for children's only drug (traditional Chinese medicine), but there were 16 and 19 treatment fields respectively were <1.00%; among the oral dosage forms, oral liquid accounted for 21.46%, while tablet, capsule, pill and other oral solid accounted for 37.51%. In the last 10 years of domestic drugs on the market, the number of approvals for regulation of water, electrolytes and acid-base balance drugs, analgesic, antipyretic, anti-inflammatory, anti-rheumatic, anti-gout drugs and respiratory drugs accounted for 64.29% of children's only drug(chemicals and biologics, excluding vaccines), the number of approvals for internal medicine-expectorant, antitussive, antiasthmatic agent, exterior-relieving agent and heat-clearing agent accounted for 61.70% of children's only drug(traditional Chinese medicine).

CONCLUSION There has been a certain basis for the marketing of pediatric drugs in China, but children's only drugs are few overall. The availability of pediatric drugs varies significantly among treatment fields. Some fields are in short supply, while others are in excess supply. Most fields are difficult to meet the drug demand of children, and the R&D and production of children's only drug is still concentrated on traditionally strong fields.