To conduct a comparative analysis of oral dosage forms listed in the Pharmacopoeia of the People's Republic of China 2025 (ChP) and the International Pharmacopoeia 12th edition (Ph.Int.) to generate foundational evidence for optimizing dosage form monographs in the Chinese Pharmacopoeia, facilitating the inclusion of pediatric-appropriate formulations, and enhancing harmonization with international standards.

A systematic literature review and side-by-side comparison were conducted to examine how each compendium names medicinal products and describes oral dosage forms; pediatric suitability was then scored against international and domestic quality criteria for child-appropriate formulations.

Compared with the ChP, the Ph.Int. embeds a formal nomenclature rule for drug products and appends explicit guidance on pediatric-appropriate formulations as well as minimum labelling/package-insert requirements-elements entirely absent from the current ChP. The ChP includes nine first-level categories encompassing 34 secondary oral dosage forms except traditional Chinese medicine preparations, whereas the Ph.Int. includes four first-level categories with 17 secondary oral dosage forms. Harmonization analysis revealed 12 dosage forms with concordant nomenclature and definitions; five with identical names but divergent definitions; 15 exclusively in ChP (7 with Ph.Int. mappings); and four exclusively in Ph.Int. (all mapped to ChP counterparts). When judged against international pediatric-usability criteria, 47% (8/17) of Ph.Int. oral monographs and 44% (15/34) of ChP entries are suitable for pre-school children or younger. Strikingly, three of the four Ph.Int.-only formulations demonstrate good acceptability for infants and toddlers, underscoring a ready opportunity for ChP expansion.

ChP should draw on Ph.Int. experience to expand its general monographs, rationalize dosage-form classification, and expedite the inclusion of pediatric-friendly oral formulations for children under six. It is suggested to establish a joint working group composed of functional departments to enhance harmonization between the Pharmacopoeia and guidance policies/formularies for clinically commonly used medicines, improve public accessibility to drugs, and concurrently strengthen alignment with the International Pharmacopoeia.