各国生物类似药说明书管理的比对研究及完善我国生物类似药说明书管理的建议
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摘要
对生物类似药的说明书进行规范管理,对指导医生合理用药、保证用药安全至关重要。通过对美欧日加等国家及我国生物类似药说明书管理要求进行比对研究,提炼管理要素;结合我国说明书的现状、设计问卷、开展调研和专家研讨;综合对比研究、调研和研讨,提出完善我国生物类似药说明书管理要求的建议和建议的考量。
It is very important to standardize and manage the instructions of biosimilar drugs for guiding doctors to use drugs reasonably and to ensure the safety of drug use.In this paper, the management requirements of biosimilar drug specifications in the United States, Europe, Japan, Canada and other countries and China were compared and studied to extract the management elements.Combined with the current situation of China's manual, questionnaire was designed, the research was carried out and the discussion was experted. Based on the comprehensive comparative study, investigation and discussion, the Suggestions and considerations for improving the management requirements of biosimilar drug specifications in China are put forward.
It is very important to standardize and manage the instructions of biosimilar drugs for guiding doctors to use drugs reasonably and to ensure the safety of drug use.In this paper, the management requirements of biosimilar drug specifications in the United States, Europe, Japan, Canada and other countries and China were compared and studied to extract the management elements.Combined with the current situation of China's manual, questionnaire was designed, the research was carried out and the discussion was experted. Based on the comprehensive comparative study, investigation and discussion, the Suggestions and considerations for improving the management requirements of biosimilar drug specifications in China are put forward.
引文
[1]国家药品监督管理局.生物类似药研发与评价技术指导原则(试行)[EB/OL].(2015-02-28)[2018-07-26].http://www.nmpa.gov.cn/WS04/CL2138/300003.html.
[2]FDA.Labeling for biosimilar products guidance for industry[EB/OL].[2018-07].https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida nces/UCM493439.pdf.
[3]Health Canada.Product monograph template-schedule D-biosimilar biologic drug[EB/OL].(2017-05-15)[2018-07-11].https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/product-monograph/product-monogr aph-template-schedule-biosimilar-biologic-drug.html#pmi.
[4]国家药典委员会.生物制品通用名命名指南[EB/OL].(2018-11-21)[2019-02-26].http://www.chp.org.cn/view/ff80808166ed5beb0167394c535879c1?a=BZSWZP.
[5]李洁,张彦彦,张薰文,等.各国生物类似药法规体系框架对比研究及完善我国生物类似药法规体系框架的建议[J].现代药物与临床,2019,34(4):889-895.
[2]FDA.Labeling for biosimilar products guidance for industry[EB/OL].[2018-07].https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida nces/UCM493439.pdf.
[3]Health Canada.Product monograph template-schedule D-biosimilar biologic drug[EB/OL].(2017-05-15)[2018-07-11].https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/product-monograph/product-monogr aph-template-schedule-biosimilar-biologic-drug.html#pmi.
[4]国家药典委员会.生物制品通用名命名指南[EB/OL].(2018-11-21)[2019-02-26].http://www.chp.org.cn/view/ff80808166ed5beb0167394c535879c1?a=BZSWZP.
[5]李洁,张彦彦,张薰文,等.各国生物类似药法规体系框架对比研究及完善我国生物类似药法规体系框架的建议[J].现代药物与临床,2019,34(4):889-895.