中成药非处方药遴选与转换中适应证评价规范性探讨

Normative study for indication assessment in process of selection and switch of OTC Chinese medicine

文章从实际工作出发,在简述我国非处方药适应证研究背景及分析中成药非处方药适应证评价研究必要性基础上,探讨我国非处方药遴选与转换中中成药适应证评价的规范性。规范适应证评价有助于增强非处方药评价的科学与公正、推进中成药非处方药转换评价工作的开展,并对保障中成药非处方药自我药疗状态下的安全有效具有重要的现实意义。

This article departed from the actual work,studied on normative for indication assessment in process of selection and switch of OTC Chinese Medicine based on the brief introduction about the study background of non-prescription drugs in our country and analysis the necessity about the indication assessment of OTC Chinese Medicine.The normative for indication assessment is contribute to strengthen the science and fairness during the evaluation of OTC drugs,push on the development of switch evaluation of OTC Chinese Medicine,and has important practical significance for ensuring OTC Chinese Medicine safe and effective when they are used in the situation of self-medication by consumers.