摘要
标准体系是指一定范围内的标准按其内在联系形成的科学的有机整体.药品标准体系的完善程度对药品安全的保障起到举足轻重的作用.药典是药品标准体系的核心.本文通过梳理《中国药典》、美国药典-国家处方集、欧洲药典、日本药典体系架构,从总体架构、各论标准架构、凡例架构、通用技术要求架构和其他标准架构,以及各类型标准的执行方式等方面进行比较,旨在为《中国药典》标准体系的优化完善提供参考借鉴.
Abstract
The standard system refers to the scientific organic whole formed by the internal connections of stand-ards within a certain range.The completeness of the drug standard system plays a crucial role in ensuring drug safety.Pharmacopoeia is the core of the drug standard system.This article compared the architecture of the Chi-nese Pharmacopoeia,the United States Pharmacopoeia,the European Pharmacopoeia,and the Japanese Pharma-copoeia on the aspects of overall architecture,monographs architecture,general notice architecture,general tech-nical requirements architecture,and other standard architecture,as well as the implementation of various types of standards,aiming to provide reference for the optimization and improvement of the standard system of the Chinese Pharmacopoeia.
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