Study on the simplified registration pathway for over-the-counter traditional Chinese medicines
MO Qi-hui
LI Ze-yu
LI Yuan-heng
ZHANG Lu-na
DONG Chen-dong
WANG Yong
YANG Yue
Abstract：Objective:To provide suggestions for optimizing the marketing registration pathway for over-the-counter traditional Chinese medicines(OTC TCMs)in China.Methods:A comparative analysis was conducted on the simplified registration system for traditional herbal medicines in the European Union,OTC Kampo preparations in Japan,and TCM marketing in China.The comparison focused on review agencies,regulatory frameworks,classification and simplified registration pathways,and documentation requirements.Based on international experience,suggestions for improving China's simplified registration management for OTC TCMs were proposed.Results:Regulatory authorities in Japan and the EU have established production standards for traditional medicines based on traditional use experience and specific literature as substantial evidence of safety and efficacy.For products meeting these standards,non-clinical or clinical trial requirements may be exempted to avoid unnecessary duplication of testing.Conclusions:China should further clarify the categories of TCMs eligible for direct OTC registeration,establish OTC TCM production standards,and appropriately simplify the listing and declaration requirements for TCMs expedite market entry and promote innovation in OTC TCMs.
Keywords：traditional Chinese medicineOTC drugsregistration managementsimplified registrationregistered classification
Publication Date：2026-01-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 17-23 )