中成药说明书法律规制现状及对策研究

Research on the Current Legal Regulation Status and Strategies of Proprietary Chinese Medicines Instructions

中成药说明书撰写不规范是制约中成药发展的一大难题。当前中成药说明书仍面临法律规范更新滞后、药品上市许可持有人在说明书撰写方面保留一定自由空间和监管体系有待进一步完善等法律规制现状,导致患者知情权受损,用药安全失去保证。本文从中成药说明书自身入手,从法律视角剖析其特殊性,对中成药说明书的法律属性进行分析和阐释,并针对其法律规制现状提出合理的完善建议,为中成药持续性发展提供规范化保障。

The non-standard writing of proprietary Chinese medicine(PCM)instructions is a major challenge to the development of PCM.At present,PCM instructions face legal regulation issues such as outdated legal norms,limited responsibilities of the marketing authorization holder(MAH)in writing instructions,and incomplete regulatory systems,resulting in compromised patient rights and drug safety.This article starts from PCM instructions,analyzes its particularity from the legal perspective,analyzes and interprets the legal attributes of PCM instructions,and puts forward reasonable suggestions for improving the legal regulation of PCM,so as to provide a standardized guarantee for the sustainable development of PCM.