Current Descriptions of Functions in Package Inserts of Chinese Herbal Patent Medicines

doi:10.19803/j.1672-8629.20240666

Abstract

Abstract: Objective To analyze the current descriptions of functions in package inserts of Chinese herbal patent medicines and propose corresponding countermeasures in order to provide a reference for marketing authorization holders (MAHs). Methods The information about package inserts of Chinese herbal patent medicines was retrieved from the official website of the National Medical Products Administration, the Pharmacopoeia of the People's Republic of China (2020 edition), and from standards for pharmaceuticals at each level. A standard for determining descriptions of functions and retrieving terms of functions was established before a manual review and analysis of the results of retrieval were conducted. Results and Conclusion The descriptions of functions and indications in most of the package inserts of Chinese herbal patent medicines meet the current standards. However, the descriptions should be standardized and made more consistent with the targeted indications.

Key words: Chinese Herbal Patent Medicines, Package Inserts, Functional Description, Standardization, Status Analysis

CLC Number:

R994.11

ZHANG Meiwei, LI Keqian, YAO Keyu, ZHU Yan. Current Descriptions of Functions in Package Inserts of Chinese Herbal Patent Medicines[J]. Chinese Journal of Pharmacovigilance, 2025, 22(2): 193-196.

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URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20240666

https://zgywjj.magtechjournal.com/EN/Y2025/V22/I2/193

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