Revision of safety information in instructions of traditional Chinese patent medicines and simple preparations

doi:10.19803/j.1672-8629.20230315

Abstract

Abstract: Objective To study how to revise the safety information items in instructions for traditional Chinese patent medicines and simple preparations. Methods With reference to the Technical Guidelines for the Revision of Safety Information Items in the Instructions of Listed Traditional Chinese Medicine (Trial) (No. 1 in 2022), this paper analyzed the contents of such warnings as “taboos”, “adverse reactions”, “precautions” and “medications for special groups” in the instructions for traditional Chinese patent medicines and simple preparations, and offered recommendations in combination with the practical experience associated with the revision of safety information items in these instructions. Results and Conclusion Marketing authorization holders can improve the safety information items in the instructions by supplementing the missing items, standardizing related terminology, and correctly labeling safety information. During the process of revision, marketing authorization holders are to conduct exhaustive search of safety information by different means, and sort out and analyze the retrieved information as items of evidence that underlie any revision. The safety information items in the instructions for traditional Chinese patent medicines and simple preparations should be revised on this basis so as to provide more accurate guidance for clinical use of traditional Chinese patent medicines and simple preparations.

Key words: Chinese patent drugs, instructions, safety information, revision, marketing authorization holder

CLC Number:

R994.1

LEI Chao, QIAO Meng, CHEN Zijia, ZHANG Qiang, XIE Yanming, WANG Zhifei. Revision of safety information in instructions of traditional Chinese patent medicines and simple preparations[J]. Chinese Journal of Pharmacovigilance, 2023, 20(12): 1396-1400.

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