OBJECTIVE

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To compare the dosage forms and specifications of over-the-counter drug （OTC） （chemical drugs） for children at home and abroad， and to provide reference for the addition of new dosage forms and specifications of OTC for children in China.

METHODS

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Data analysis was used to comb the active ingredients of OTC single-ingredient preparation for children in China. The similarities and differences of the dosage forms and specifications of OTC for children with the same active ingredients among China and 8th edition of

WHO Model List of Essential Medicines for Children

（WHO EMLc） and US/UK/EU （this article refers specifically to EU countries）/Japan were analyzed by comparative analysis.

RESULTS

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There were 72 active ingredients of OTC single-ingredient preparation for children in China， corresponding to 34 dosage forms and 216 specifications； 39 same active ingredients of OTC for children were retrieved in WHO EMLc and US/UK/EU/Japan， corresponding to 38 dosage forms and 258 specifications. Among OTC for children corresponding to 39 active ingredients， there were 10 unique dosage forms in China， and 16 unique dosage forms in WHO EMLc and US/UK/EU/Japan， of which some dosage forms have advantages for children （such as chewing gums， gels for external use， spray for oral liquid， etc.）， were included in the latter while not included in China. There were 107 unique specifications in China， and 214 unique specifications in WHO EMLc and US/UK/EU/Japan， of which the division of applicable age groups for specifications was more detailed. In addition， the dosage forms and specifications corresponding to a few active ingredients （such as ibuprofen， cetirizine hydrochloride） were not included in OTC for children in China， while included in UK/EU.

CONCLUSIONS

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The dosage forms and specifications of OTC for children in WHO EMLc and US/UK/EU/Japan are generally more abundant and flexible than in China. Relevant departments in China should learn from the advanced experience of WHO and foreign countries and increase the research and development of dosage forms and specifications of OTC for children.