T/CNPPA 3021-2022 Children's Drug Label Design Guidelines

Scope

Main technical content: Children are not miniature adults. There are significant differences in their ability to absorb, distribute, metabolize, and excrete drugs compared to adults, and different physiological characteristics exist in different age groups. Drugs used on children have age restrictions or dosage requirements. Distinguishing children's drugs from adult drugs on the label, or providing clear prompts on important content involving children's use, can prevent misuse from causing harm to children. Therefore, in addition to meeting the basic requirements for drug label design, children's drug labels need to consider the characteristics of children's drugs, and important safety information should be clearly marked on the label. This document aims to guide drug marketing authorization holders and label designers and manufacturers to increase the recognizability of label content, reduce clinical medication errors in children, and ensure medication safety when designing drug labels. This document is formulated in accordance with the "Drug Administration Law of the People's Republic of China", the "Regulations on the Management of Drug Instructions and Labels" (Decree No. 24 of the National Medical Products Administration, issued in 2006), and T/CNPPA3004-2019. This document is intended for reference by drug marketing authorization holders and label designers and manufacturers, subject to compliance with relevant national regulations. All the images in this document are schematic diagrams, and the drug names appearing in the diagrams are only used for auxiliary explanation and have no relation to the actual drug attributes.

Development Information

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