美国国家药品编码目录在参比制剂可及性方面的应用简介
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摘要
美国橙皮书收录的参比制剂(RLD)是我国仿制药参比制剂的一个重要参考,因此,其可及性对企业顺利开展仿制药质量和疗效一致性评价工作具有重要影响。美国国家药品编码(NDC)是每个药品独特的、3段式数字形式编号,为该药品的通用标识号,国家药品编码目录收载了进入商品流通领域的所有处方药和非处方药的信息。本文系统阐述了国家药品编码的组成形式及其目录的发展概况。同时,以我国仿制药参比制剂目录(第一批)与美国橙皮书收载的参比制剂为例,介绍了国家药品编码目录在参比制剂可及性方面的应用,可有助于企业查询、辨别和购买参比制剂。
The reference listed drug( RLD) in the USA orange book is the important source of the Chinese reference listed drug for generic drug applicants,and its availability has the significant impact for pharmaceutical enterprise to carry out the re-evaluation of generic drug product. The national drug code( NDC) is the unique,3-segment number for each drug product in USA,and serves as a universal product identifier for drugs; while the NDC directory adopts the information of drug products in the current commercial distribution,including all of the prescription drug and over the counter drug. The composition and configuration of the NDC,as well as the development history of the NDC directory,were systemically elaborated in this paper. The application of the NDC directory was discussed by comparison of Chinese reference listed drug of generic drug product( first batch) with RLD listed in USA orange book. NDC directory and its availability are useful information for pharmaceutical enterprise to source,identify and purchase the suitable RLD sourced from USA orange book.
The reference listed drug( RLD) in the USA orange book is the important source of the Chinese reference listed drug for generic drug applicants,and its availability has the significant impact for pharmaceutical enterprise to carry out the re-evaluation of generic drug product. The national drug code( NDC) is the unique,3-segment number for each drug product in USA,and serves as a universal product identifier for drugs; while the NDC directory adopts the information of drug products in the current commercial distribution,including all of the prescription drug and over the counter drug. The composition and configuration of the NDC,as well as the development history of the NDC directory,were systemically elaborated in this paper. The application of the NDC directory was discussed by comparison of Chinese reference listed drug of generic drug product( first batch) with RLD listed in USA orange book. NDC directory and its availability are useful information for pharmaceutical enterprise to source,identify and purchase the suitable RLD sourced from USA orange book.
引文
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[2]国家食品药品监督管理总局.总局关于发布仿制药参比制剂目录(第十三批)的通告(2018年第38号)[EB/OL].[2018-02-14].http://www.sda.gov.cn/WS01/CL1751/224948.html.
[3]FDA.Approved drug products with therapeutic equivalence evaluations(orange book)[EB/OL].[2017-01-01].https://www.fda.gov/downloads/Drugs/Development Approval Process/UCM071436.pdf.
[4]FDA.National drug code database background information[EB/OL].[2017-03-20].https://www.fda.gov/Drugs/DevelopmentApprovalProcess/UCM070829.
[5]FDA.Federal food,drug,and cosmetic act(FD&C Act)[EB/OL].[2018-02-07].https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/federalfooddrugandcosmeticactfdcact/default.htm.
[6]FDA.National drug code directory[EB/OL].[2017-11-09].https://www.fda.gov/Drugs/Information On Drugs/ucm142438.htm.
[7]FDA.Drug registration and listing system(DRLS and e DRLS)[EB/OL].[2017-06-13].https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/default.htm.
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[9]FDA.Guidance for Industry:providing regulatory submissions in electronic format-drug establishment registration and drug listing[EB/OL].[2009-05].https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072339.pdf.
[10]国家食品药品监督管理总局.总局关于发布仿制药参比制剂目录(第一批)的通告(2017年第45号)[EB/OL].[2017-03-17].http://www.sda.gov.cn/WS01/CL1757/170862.html.
[11]FDA.National drug code directory[EB/OL].[2018-03-22].https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm.
[12]FDA.Drugs@FDA:FDA approved drug products[EB/OL].[2018-03-22].https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&Appl No=050605.
[13]FDA.CEFTIN(cefuroxime axetil)tablets,for oral use[EB/OL].[2017-10-13].https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050605s050,050672s036lbl.pdf.
[14]FDA.Orange book:approved drug products with therapeutic equivalence evaluations[EB/OL].[2018-02].https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm.
[15]FDA.Referencing approved drug products in ANDA submissions,DRAFT GUIDANCE,January 2017[EB/OL].[2017-01].https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm536962.pdf.
[2]国家食品药品监督管理总局.总局关于发布仿制药参比制剂目录(第十三批)的通告(2018年第38号)[EB/OL].[2018-02-14].http://www.sda.gov.cn/WS01/CL1751/224948.html.
[3]FDA.Approved drug products with therapeutic equivalence evaluations(orange book)[EB/OL].[2017-01-01].https://www.fda.gov/downloads/Drugs/Development Approval Process/UCM071436.pdf.
[4]FDA.National drug code database background information[EB/OL].[2017-03-20].https://www.fda.gov/Drugs/DevelopmentApprovalProcess/UCM070829.
[5]FDA.Federal food,drug,and cosmetic act(FD&C Act)[EB/OL].[2018-02-07].https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/federalfooddrugandcosmeticactfdcact/default.htm.
[6]FDA.National drug code directory[EB/OL].[2017-11-09].https://www.fda.gov/Drugs/Information On Drugs/ucm142438.htm.
[7]FDA.Drug registration and listing system(DRLS and e DRLS)[EB/OL].[2017-06-13].https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/default.htm.
[8]FDA.Electronic registration and listing compliance program[EB/OL].[2018-03-09].https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm531142.htm.
[9]FDA.Guidance for Industry:providing regulatory submissions in electronic format-drug establishment registration and drug listing[EB/OL].[2009-05].https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072339.pdf.
[10]国家食品药品监督管理总局.总局关于发布仿制药参比制剂目录(第一批)的通告(2017年第45号)[EB/OL].[2017-03-17].http://www.sda.gov.cn/WS01/CL1757/170862.html.
[11]FDA.National drug code directory[EB/OL].[2018-03-22].https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm.
[12]FDA.Drugs@FDA:FDA approved drug products[EB/OL].[2018-03-22].https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&Appl No=050605.
[13]FDA.CEFTIN(cefuroxime axetil)tablets,for oral use[EB/OL].[2017-10-13].https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050605s050,050672s036lbl.pdf.
[14]FDA.Orange book:approved drug products with therapeutic equivalence evaluations[EB/OL].[2018-02].https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm.
[15]FDA.Referencing approved drug products in ANDA submissions,DRAFT GUIDANCE,January 2017[EB/OL].[2017-01].https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm536962.pdf.