中国药事
中國藥事
중국약사
CHINESE PHARMACEUTICAL AFFAIRS
2014年
10期
1125-1128
,共4页
国家药品标准%试行标准%化学药品标准%标准转正
國傢藥品標準%試行標準%化學藥品標準%標準轉正
국가약품표준%시행표준%화학약품표준%표준전정
national drug standards%tentative standard%standards for chemical medicines%regularity
目的：探讨药品标准分类及管理情况，为顺利完成化学药品新药试行标准转正工作提供参考。方法总结我国药品标准分类的历史沿革，阐明化学药品新药试行标准转正工作的背景和意义。分析了化学药品新药试行标准转正工作涉及的各种情况，包括：已经收载于《中国药典》的品种；已有新国标的品种；经过修订提高标准的品种；部分厂家已有国标的品种和未有国标品种的处理原则。结果与结论通过药品标准转正工作，药品标准的标准化管理优势将进一步得到体现，但暂时未能彻底解决统一药品标准的问题，在一定时间内，还存在着同一品种不同标准的局面。国家相关部门应持续开展药品标准提高修订与统一工作，形成健全的药品标准体系，为药品生产企业创建公平的市场竞争环境，以药品质量的提高确保人民用药的安全有效。
目的：探討藥品標準分類及管理情況，為順利完成化學藥品新藥試行標準轉正工作提供參攷。方法總結我國藥品標準分類的歷史沿革，闡明化學藥品新藥試行標準轉正工作的揹景和意義。分析瞭化學藥品新藥試行標準轉正工作涉及的各種情況，包括：已經收載于《中國藥典》的品種；已有新國標的品種；經過脩訂提高標準的品種；部分廠傢已有國標的品種和未有國標品種的處理原則。結果與結論通過藥品標準轉正工作，藥品標準的標準化管理優勢將進一步得到體現，但暫時未能徹底解決統一藥品標準的問題，在一定時間內，還存在著同一品種不同標準的跼麵。國傢相關部門應持續開展藥品標準提高脩訂與統一工作，形成健全的藥品標準體繫，為藥品生產企業創建公平的市場競爭環境，以藥品質量的提高確保人民用藥的安全有效。
목적：탐토약품표준분류급관리정황，위순리완성화학약품신약시행표준전정공작제공삼고。방법총결아국약품표준분류적역사연혁，천명화학약품신약시행표준전정공작적배경화의의。분석료화학약품신약시행표준전정공작섭급적각충정황，포괄：이경수재우《중국약전》적품충；이유신국표적품충；경과수정제고표준적품충；부분엄가이유국표적품충화미유국표품충적처리원칙。결과여결론통과약품표준전정공작，약품표준적표준화관리우세장진일보득도체현，단잠시미능철저해결통일약품표준적문제，재일정시간내，환존재착동일품충불동표준적국면。국가상관부문응지속개전약품표준제고수정여통일공작，형성건전적약품표준체계，위약품생산기업창건공평적시장경쟁배경，이약품질량적제고학보인민용약적안전유효。
Objective To discuss classification and management of drug standards and provide a reference for regularization of the tentative standard of new chemical medicines.Methods The evolution history of drug standard classification in our country was summarized.The background and significance of regularization of the tentative standard of new chemical medicines were clarified.The various situations involved in regularization of the tentative standard of new chemical medicines were analyzed,including drugs recorded in China Pharmacopoeia,drugs with new existing national standards,drugs with revised and improved standards,drugs with existing national standards produced by certain manufacturers and management principles for drugs with no national standards. Results and Conclusion Through the regularization work for the tentative standard, standardization management advantages will be further reflected,but for the moment,the problem of disunity of standards has not yet been completely solved and there exist different standards for one same variety.Relevant departments of the government should constantly carry out the work of standard unification and improvement to form a sound system of drug standards,thus to create a fair market competition environment for drug production enterprises and ensure the safety and effectiveness of drugs with the improvement of drug quality.
