中药说明书规格表述若干问题探讨

Discussion on some problems of specification statements of traditional Chinese medicines

药品规格与用法用量关联性不强、包装等项目表述不规范、说明书存在信息不规范、不完整的问题,给患者和医师造成困惑。近年,监管部门越来越重视中药说明书的规范化问题,积极推动中成药管理向科学规范的方向发展。生产企业应自觉履行企业主体责任,与时俱进,对说明书相关要求认真研读,主动提高说明书撰写能力。本文就药品审评中遇到的一些问题进行讨论,供业界参考。

There are some common problems in the labelings of traditional Chinese medicines.Drug specifications and dosage are not closely related,and the descriptions of packaging and other items are not standardized.The information is irregular and incomplete,which causes confusion to patients and doctors.In recent years,the regulatory authorities have paid more and more attention to the standardization of the labelings for traditional Chinese medicines,and actively promoted the management of traditional Chinese medicine to develop in a scientific and standard direction.The pharmaceutical enterprises should conscientiously fulfill the principal responsibility of the enterprises,keep pace with the times,carefully study the related requirements of labeling,and actively improve the writing ability of labeling.This paper discusses some problems encountered in the review of submmitted labelings to provide reference for industry.