CAJ | 학술논문

本文对英国药品标准制度进行了较为详尽的评介。英国药品标准的内容包括《英国药典》、《欧洲药典》、《英国批准药名》、药品标准物质以及非法定的药品标准，英国药品标准制定的组织架构包括英国药典委员会及其专家咨询组、专家小组和工作组以及秘书处和药典实验室，标准制定程序清晰明确。《英国药典》具有重要的法律约束力，凡是《英国药典》专论中规定的医药产品，在英国境内的销售或供应都必须符合药典规定。英国药品标准制度对中国药品标准制度改革的启示在于，应促进药品标准的科学管理，完善药品标准制定的组织架构，及时修订药品标准，进一步促进药品标准的国际化。
본문대영국약품표준제도진행료교위상진적평개。영국약품표준적내용포괄《영국약전》、《구주약전》、《영국비준약명》、약품표준물질이급비법정적약품표준，영국약품표준제정적조직가구포괄영국약전위원회급기전가자순조、전가소조화공작조이급비서처화약전실험실，표준제정정서청석명학。《영국약전》구유중요적법률약속력，범시《영국약전》전론중규정적의약산품，재영국경내적소수혹공응도필수부합약전규정。영국약품표준제도대중국약품표준제도개혁적계시재우，응촉진약품표준적과학관리，완선약품표준제정적조직가구，급시수정약품표준，진일보촉진약품표준적국제화。
The paper presents a detailed review of British pharmaceutical standards including British Pharma-copoeia, European Pharmacopoeia, British Approved Names, Reference Standards and Non-Statutory Pharmaceutical Standards. British pharmaceutical standards are established by the British Pharmacopoeia Commission, Expert Advi-sory Groups, Panels of Experts and Working Parties, British Pharmacopoeia Commission Secretariat, British Pharma-copoeia Laboratory, and standard-setting procedures are clear and definite. British Pharmacopoeia standards are le-gally binding, and pharmaceutical products sold in the United Kingdom must comply with pharmacopoeia require-ments. British pharmaceutical standards can serve as an important reference for reforms to China’s pharmaceutical standards, including the scientific management of pharmaceutical standards, the improvement of organizational frame-works in the establishment pharmaceutical standards, the promptness of amendments to pharmacopoeia, and the uni-versality of international exchanges.