英国药品标准法律制度评介

Overview of the British pharmaceutical standard-setting system

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。

The paper presents a detailed review of British pharmaceutical standards including British Pharmacopoeia,European Pharmacopoeia,British Approved Names,Reference Standards and Non-Statutory Pharmaceutical Standards. British pharmaceutical standards are established by the British Pharmacopoeia Commission,Expert Advisory Groups,Panels of Experts and Working Parties,British Pharmacopoeia Commission Secretariat,British Pharmacopoeia Laboratory,and standard-setting procedures are clear and definite. British Pharmacopoeia standards are legally binding,and pharmaceutical products sold in the United Kingdom must comply with pharmacopoeia requirements. 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 frameworks in the establishment pharmaceutical standards,the promptness of amendments to pharmacopoeia,and the universality of international exchanges.