再谈Expiration date的翻译问题
|
摘要
目的:国内学界对于Expiration date是译为"失效期"还是译为"有效期"素有质疑和分歧。为此,本文再次探讨了Expiration date的正确译法。方法:采用文献分析法对国际上权威标准和指南中Expiration date的定义和解释进行分析,与我国失效期、有效期等相关概念的定义进行对比分析。结果:根据国际上的定义,在Expiration date当天,药品仍是符合标准的。这与目前我国对药品失效期的定义和解释并不一致,将其翻译为"失效期"是不准确的。另外,Expiration date和有效期在法律上分别属于"期日"和"期间"的概念,将Expiration date简单译为"有效期"也是不准确的。结论:Expiration date是有效期的最后一天,作为辅助期日起到了确定有效期(期间)终点的作用。Expiration date也是用于药品容器标签上的有效期的标注方法,可将其直译为"有效期终止日期"等,也可根据《药品说明书和标签管理规定》中规定的有效期的标注方法将其译为"有效期至"。
Objective:There have long been queries and debates on whether "expiration date"should be translated as"shixiaoqi"or"shelf life"in Chinese.Therefore,correct translation of the term was put forward for discussion in the paper.Methods:By literature analysis,various definitions of expiration date in international authoritative standards and guidelines were screened and analyzed.And in the meantime,the definitions of related terms,such as shixiaoqi and shelf life in China were analyzed and compared.Results:According to the international definitions,on the day of expiration,a certain medicinal product still remains within specifications,which evidently does not conform to the explanation of shixiaoqi in China.Therefore,it is not correct to translate expiration date as"shixiaoqi".In addition,expiration date is a juristic concept of"date"and shelf life is a juristic concept of"period".Therefore,it is not accurate to translate expiration date simply as"shelf life".Conclusion:Expiration date is the last day of shelf life,which is used on the container label of a drug product to indicate the end of shelf life.Therefore,it can be literally translated as the"ending date of shelf life",or translated as"valid until a certain date".
Objective:There have long been queries and debates on whether "expiration date"should be translated as"shixiaoqi"or"shelf life"in Chinese.Therefore,correct translation of the term was put forward for discussion in the paper.Methods:By literature analysis,various definitions of expiration date in international authoritative standards and guidelines were screened and analyzed.And in the meantime,the definitions of related terms,such as shixiaoqi and shelf life in China were analyzed and compared.Results:According to the international definitions,on the day of expiration,a certain medicinal product still remains within specifications,which evidently does not conform to the explanation of shixiaoqi in China.Therefore,it is not correct to translate expiration date as"shixiaoqi".In addition,expiration date is a juristic concept of"date"and shelf life is a juristic concept of"period".Therefore,it is not accurate to translate expiration date simply as"shelf life".Conclusion:Expiration date is the last day of shelf life,which is used on the container label of a drug product to indicate the end of shelf life.Therefore,it can be literally translated as the"ending date of shelf life",or translated as"valid until a certain date".
引文
[1]国家食品药品监督管理总局.化学药物(原料药和制剂)稳定性研究技术指导原则(修订)[EB/OL].(2015-02-05)[2018-06-30].http://samr.cfda.gov.cn/WS01/CL1616/114289.html.China Food and Drug Administration.Guidance of stability testing of drug substances and products(revised)[EB/OL].(2015-02-05)[2018-06-30].http://samr.cfda.gov.cn/WS01/CL1616/114289.html.In Chinese.
[2]中华人民共和国药品管理法与药品管理实务全书编委会.中华人民共和国药品管理法与药品管理实务全书(上卷)[M].北京:中国物价出版社,2001:455.Encyclopedia of pharmaceutical administration law of the People's Republic of China and pharmaceutical administration practice Editorial Board.Encyclopedia of pharmaceutical administration law of the People's Republic of China and pharmaceutical administration practice(Volumn 1)[M].Beijing:China Price Press,2001:455.In Chinese.
[3]陈宜彬,杨福兴.Expiration date宜译为有效期[J].中国医院药学杂志,1987,7(9):430.CHEN Yibin,YANG Fuxing.Expiration date is better to be translated as shelf life[J].Chin J Hosp Pharm,1987,7(9):430.In Chinese.
[4]陈莲珍,王育琴,闻满华,等.关于药品效期用语“Expiry”的理解[J].中国药学杂志,2000,35(3):176.CHEN Lianzhen,WANG Yuqin,WEN Manhua,et al.Understanding of“Expiry”[J].Chin Pharm J,2000,35(3):176.In Chinese.
[5]吴伯镛.关于药品效期用词“Expiry”的质疑[J].中国药学杂志,2001,36(5):330.WU Boyong.Query about“Expiry”[J].Chin Pharm J,2001,36(5):330.In Chinese.
[6]药学名词审定委员会.药学名词[M].2版.北京:科学出版社,2014:13,158.Judgement Committee of Terminology in Pharmacy.Terminology in pharmacy[M].2nd ed.Beijing:Science Press,2014:13,158.In Chinese.
[7]苏艳芳.商品学概论[M].北京:中国财富出版社,2014:198.SU Yanfang.Generality of commodity science[M].Beijing:China Fortune Press,2014:198.In Chinese.
[8]孙东风.药品监督管理简明词语手册[M].北京:中国医药科技出版社,2003:45.SUN Dongfeng.Concise term handbook of drugs supervision and administration[M].Beijing:China Medical Science Press,2003:45.In Chinese.
[9]World Health Organization.Guide to good storage practices for pharmaceuticals[EB/OL](2016-09).[2017-10-11].http://www.who.int/medicines/areas/quality_safety/quality_assurance/GuideGoodStoragePracticesTRS908Annex9.pdf?ua=1.
[10]The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.Stability testing of new drug substances and products[EB/OL].(2003-02-06)[2017-10-11].http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf.
[11]United States Pharmacopeial Convention.USP39-NF34[S].Rockille,United States Pharmacopeial Convention,Inc,2015:101.
[12]杨元刚.新编汉英翻译教程[M].武汉:华中师范大学出版社,2012:243.YANG Yuangang.A new coursebook of Chinese-English translation[M].Wuhan:Huazhong Normal University Press,2012:243.In Chinese.
[13]李雅茹.药品的批号与有效期(或失效期)的关系及识别方法[J].天津药学,1998,10(2):102-103.LI Yaru.Relationship between drug batch number and expiration date and recognition method[J].Tianjin Pharm,1998,10(2):102-103.In Chinese.
[14]Consumer Healthcare Products Association.Voluntary codes and guidelines[EB/OL](2015-08).[2017-10-11].https://www.chpa.org/PDF/VolCodesGuidelines.aspx.
[15]徐武生,靳宝兰.民法学[M].2版.北京:中国人民公安大学出版社,2014:148.XU Wusheng,JIN Baolan.Civil law[M].2nd ed.Beijing:Chinese People's Public Security University Press,2014:148.In Chinese.
[16]国家食品药品监督管理局.关于印发化学药品和生物制品说明书规范细则的通知[EB/OL].(2006-05-10)[2018-06-30].http://samr.cfda.gov.cn/WS01/CL0844/10528.html.China Food and Drug Administration.Notice for issuing the package insert regulations of chemical medicine and biological products[EB/OL].(2006-05-10)[2018-06-30].http://samr.cfda.gov.cn/WS01/CL0844/10528.html.In Chinese.
[17]刘凯湘.民法学[M].北京:中国法制出版社,2007:149.LIU Kaixiang.Civil law[M].Beijing:China Legal Publishing House,2007:149.In Chinese.
[18]中华人民共和国卫生部办公厅.中华人民共和国卫生法规汇编(1978年-1980年)[M].北京:法律出版社,1982:337-343.Department of General Administration of Health Ministry of the People's Republic of China.Health laws and regulations of the People's Republic of China(1978-1980)[M].Beijing:Chinese Law Press,1982:337-343.In Chinese.
[19]钱信忠.中华人民共和国执业医师法实务全书[M].北京:中国民主法制出版社,1998:877-880.QIAN Xinzhong.Encyclopedia of practice of law of the People's Republic of China on medical practitioners[M].Beijing:Press of Chinese Democratic Legal System,1998:877-880.In Chinese.
[20]国家卫生部.关于颁布《中华人民共和国药典》一九九零年版的通知[J].中国药房,1991,2(2):25-26.Ministry of Health,the People's Republic of China.Notices for issuing Pharmacopoeia of the People's Republic of China(1990ed)[J].China Pharmacy,1991,2(2):25-26.In Chinese.
[21]国家卫生部.关于执行《中华人民共和国药典》1995年版有关事宜的通知[J].中国药事,1996,10(1):11-13.Ministry of Health,the People's Republic of China.Notices for the execution of the Pharmacopoeia of People's Republic of China(1995ed)[J].Chin Pharm Affairs,1996,10(1):11-13.In Chinese.
[22]国家药品管监督理局.关于颁布执行《中华人民共和国药典》2000年版的通知[J].中国药品标准,2000,1(2):5-6.State Administration of Drug Control and Supervision.Notices for issuing Pharmacopoeia of the People's Republic of China 2000[J].Drug Stand China,2000,1(2):5-6.In Chinese.
[23]国家食品药品监督管理局.化学药物稳定性研究技术指导原则[EB/OL].(2005-03-18)[2018-06-30].http://samr.cfda.gov.cn/directory/web/WS01/images/u6Rp9KpzuOyLao0NTR0L6vLzK9da4tbzUrdTyLnBkZg==.pdf.China Food and Drug Administration.Guidance of stability testing of chemical drugs[EB/OL].(2005-03-18)[2018-06-30].http://samr.cfda.gov.cn/directory/web/WS01/images/u6Rp9KpzuOyLao0NTR0L6vLzK9da4tbzUrdTyLn BkZg==.pdf.In Chinese.
[24]国家食品药品监督管理局.药品说明书和标签管理规定(局令第24号)[EB/OL].(2006-03-15)[2018-06-30].http://samr.cfda.gov.cn/WS01/CL0053/24522.html.China Food and Drug Administration.Administrative regulations for instructions and packaging label of drugs(CFDA Decree No.24)[EB/OL].(2006-03-15)[2018-06-30].http://samr.cfda.gov.cn/WS01/CL0053/24522.html.In Chinese.
[25]国家食品药品监督管理总局.国家食品药品监督管理总局成为国际人用药品注册技术协调会成员[EB/OL].(2017-06-19)[2018-06-30].http://samr.cfda.gov.cn/WS01/CL0050/173976.html.China Food and Drug Administration.CFDA becomes a member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use[EB/OL].(2017-06-19)[2018-06-30].http://samr.cfda.gov.cn/WS01/CL0050/173976.html.In Chinese.
[2]中华人民共和国药品管理法与药品管理实务全书编委会.中华人民共和国药品管理法与药品管理实务全书(上卷)[M].北京:中国物价出版社,2001:455.Encyclopedia of pharmaceutical administration law of the People's Republic of China and pharmaceutical administration practice Editorial Board.Encyclopedia of pharmaceutical administration law of the People's Republic of China and pharmaceutical administration practice(Volumn 1)[M].Beijing:China Price Press,2001:455.In Chinese.
[3]陈宜彬,杨福兴.Expiration date宜译为有效期[J].中国医院药学杂志,1987,7(9):430.CHEN Yibin,YANG Fuxing.Expiration date is better to be translated as shelf life[J].Chin J Hosp Pharm,1987,7(9):430.In Chinese.
[4]陈莲珍,王育琴,闻满华,等.关于药品效期用语“Expiry”的理解[J].中国药学杂志,2000,35(3):176.CHEN Lianzhen,WANG Yuqin,WEN Manhua,et al.Understanding of“Expiry”[J].Chin Pharm J,2000,35(3):176.In Chinese.
[5]吴伯镛.关于药品效期用词“Expiry”的质疑[J].中国药学杂志,2001,36(5):330.WU Boyong.Query about“Expiry”[J].Chin Pharm J,2001,36(5):330.In Chinese.
[6]药学名词审定委员会.药学名词[M].2版.北京:科学出版社,2014:13,158.Judgement Committee of Terminology in Pharmacy.Terminology in pharmacy[M].2nd ed.Beijing:Science Press,2014:13,158.In Chinese.
[7]苏艳芳.商品学概论[M].北京:中国财富出版社,2014:198.SU Yanfang.Generality of commodity science[M].Beijing:China Fortune Press,2014:198.In Chinese.
[8]孙东风.药品监督管理简明词语手册[M].北京:中国医药科技出版社,2003:45.SUN Dongfeng.Concise term handbook of drugs supervision and administration[M].Beijing:China Medical Science Press,2003:45.In Chinese.
[9]World Health Organization.Guide to good storage practices for pharmaceuticals[EB/OL](2016-09).[2017-10-11].http://www.who.int/medicines/areas/quality_safety/quality_assurance/GuideGoodStoragePracticesTRS908Annex9.pdf?ua=1.
[10]The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.Stability testing of new drug substances and products[EB/OL].(2003-02-06)[2017-10-11].http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf.
[11]United States Pharmacopeial Convention.USP39-NF34[S].Rockille,United States Pharmacopeial Convention,Inc,2015:101.
[12]杨元刚.新编汉英翻译教程[M].武汉:华中师范大学出版社,2012:243.YANG Yuangang.A new coursebook of Chinese-English translation[M].Wuhan:Huazhong Normal University Press,2012:243.In Chinese.
[13]李雅茹.药品的批号与有效期(或失效期)的关系及识别方法[J].天津药学,1998,10(2):102-103.LI Yaru.Relationship between drug batch number and expiration date and recognition method[J].Tianjin Pharm,1998,10(2):102-103.In Chinese.
[14]Consumer Healthcare Products Association.Voluntary codes and guidelines[EB/OL](2015-08).[2017-10-11].https://www.chpa.org/PDF/VolCodesGuidelines.aspx.
[15]徐武生,靳宝兰.民法学[M].2版.北京:中国人民公安大学出版社,2014:148.XU Wusheng,JIN Baolan.Civil law[M].2nd ed.Beijing:Chinese People's Public Security University Press,2014:148.In Chinese.
[16]国家食品药品监督管理局.关于印发化学药品和生物制品说明书规范细则的通知[EB/OL].(2006-05-10)[2018-06-30].http://samr.cfda.gov.cn/WS01/CL0844/10528.html.China Food and Drug Administration.Notice for issuing the package insert regulations of chemical medicine and biological products[EB/OL].(2006-05-10)[2018-06-30].http://samr.cfda.gov.cn/WS01/CL0844/10528.html.In Chinese.
[17]刘凯湘.民法学[M].北京:中国法制出版社,2007:149.LIU Kaixiang.Civil law[M].Beijing:China Legal Publishing House,2007:149.In Chinese.
[18]中华人民共和国卫生部办公厅.中华人民共和国卫生法规汇编(1978年-1980年)[M].北京:法律出版社,1982:337-343.Department of General Administration of Health Ministry of the People's Republic of China.Health laws and regulations of the People's Republic of China(1978-1980)[M].Beijing:Chinese Law Press,1982:337-343.In Chinese.
[19]钱信忠.中华人民共和国执业医师法实务全书[M].北京:中国民主法制出版社,1998:877-880.QIAN Xinzhong.Encyclopedia of practice of law of the People's Republic of China on medical practitioners[M].Beijing:Press of Chinese Democratic Legal System,1998:877-880.In Chinese.
[20]国家卫生部.关于颁布《中华人民共和国药典》一九九零年版的通知[J].中国药房,1991,2(2):25-26.Ministry of Health,the People's Republic of China.Notices for issuing Pharmacopoeia of the People's Republic of China(1990ed)[J].China Pharmacy,1991,2(2):25-26.In Chinese.
[21]国家卫生部.关于执行《中华人民共和国药典》1995年版有关事宜的通知[J].中国药事,1996,10(1):11-13.Ministry of Health,the People's Republic of China.Notices for the execution of the Pharmacopoeia of People's Republic of China(1995ed)[J].Chin Pharm Affairs,1996,10(1):11-13.In Chinese.
[22]国家药品管监督理局.关于颁布执行《中华人民共和国药典》2000年版的通知[J].中国药品标准,2000,1(2):5-6.State Administration of Drug Control and Supervision.Notices for issuing Pharmacopoeia of the People's Republic of China 2000[J].Drug Stand China,2000,1(2):5-6.In Chinese.
[23]国家食品药品监督管理局.化学药物稳定性研究技术指导原则[EB/OL].(2005-03-18)[2018-06-30].http://samr.cfda.gov.cn/directory/web/WS01/images/u6Rp9KpzuOyLao0NTR0L6vLzK9da4tbzUrdTyLnBkZg==.pdf.China Food and Drug Administration.Guidance of stability testing of chemical drugs[EB/OL].(2005-03-18)[2018-06-30].http://samr.cfda.gov.cn/directory/web/WS01/images/u6Rp9KpzuOyLao0NTR0L6vLzK9da4tbzUrdTyLn BkZg==.pdf.In Chinese.
[24]国家食品药品监督管理局.药品说明书和标签管理规定(局令第24号)[EB/OL].(2006-03-15)[2018-06-30].http://samr.cfda.gov.cn/WS01/CL0053/24522.html.China Food and Drug Administration.Administrative regulations for instructions and packaging label of drugs(CFDA Decree No.24)[EB/OL].(2006-03-15)[2018-06-30].http://samr.cfda.gov.cn/WS01/CL0053/24522.html.In Chinese.
[25]国家食品药品监督管理总局.国家食品药品监督管理总局成为国际人用药品注册技术协调会成员[EB/OL].(2017-06-19)[2018-06-30].http://samr.cfda.gov.cn/WS01/CL0050/173976.html.China Food and Drug Administration.CFDA becomes a member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use[EB/OL].(2017-06-19)[2018-06-30].http://samr.cfda.gov.cn/WS01/CL0050/173976.html.In Chinese.