FDA对生物类似药说明书的要求
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摘要
美国食品药品监督管理局(FDA)于2018年7月发布了"供企业用生物类似药说明书指导原则"。该指导原则提出了起草生物类似药说明书的一般原则,并对生物类似药说明书的内容提出了许多具体建议。而我国目前尚无类似的指导原则。详细介绍FDA的该指导原则主要内容,对我国撰写、阅读和监管生物类似药说明书有重要的参考价值。
FDA issued Labeling for Biosimilar Products Guidance for Industry in July 2018.This guidance puts forward the general principle of drafting the biosimilar products labeling,and submits many specific suggestions on the content of the biosimilar products labeling.And our country does not have similar guidance at present.This article describes in detail the FDA guidance for writing,reading and supervising biosimilar products labeling,which has important reference value in China.
FDA issued Labeling for Biosimilar Products Guidance for Industry in July 2018.This guidance puts forward the general principle of drafting the biosimilar products labeling,and submits many specific suggestions on the content of the biosimilar products labeling.And our country does not have similar guidance at present.This article describes in detail the FDA guidance for writing,reading and supervising biosimilar products labeling,which has important reference value in China.
引文
[1]FDA.Labeling for Biosimilar Products Guidance for Industry[EB/OL].(2018-07-18)[2018-09-15].https://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/UCM493439.pdf.
[2]FDA.Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products[EB/OL].(1998-05-14)[2018-09-15].https://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/UCM072008.pdf.
[3]FDA.Physican Labeling Rule Requirements on content and format of labeling for human prescription drug and biological products[EB/OL].(2006-01-24)[2018-09-15].https://www.fda.gov/drugs/guidancecompliance regulatoryinformation/lawsactsandrules/ucm084159.htm.
[4]FDA.Pregnancy,Lactation,and Reproductive Potential:Labeling for Human Prescription Drug and Biological Products-Content and Format Guidance for Industry Draft Guidance[EB/OL].(2014-12-03)[2018-09-15].https://www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/UCM425398.pdf.
[5]FDA.Q.I.7 in the guidance for industry Biosimilars:Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009[EB/OL].(2015-04-28)[2018-09-15].https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/UCM444661.pdf.
[6]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)[2018-09-15].http://www.cde.org.cn/zdyz.do?method=largePage&id=243.
[2]FDA.Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products[EB/OL].(1998-05-14)[2018-09-15].https://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/UCM072008.pdf.
[3]FDA.Physican Labeling Rule Requirements on content and format of labeling for human prescription drug and biological products[EB/OL].(2006-01-24)[2018-09-15].https://www.fda.gov/drugs/guidancecompliance regulatoryinformation/lawsactsandrules/ucm084159.htm.
[4]FDA.Pregnancy,Lactation,and Reproductive Potential:Labeling for Human Prescription Drug and Biological Products-Content and Format Guidance for Industry Draft Guidance[EB/OL].(2014-12-03)[2018-09-15].https://www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/UCM425398.pdf.
[5]FDA.Q.I.7 in the guidance for industry Biosimilars:Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009[EB/OL].(2015-04-28)[2018-09-15].https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/UCM444661.pdf.
[6]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)[2018-09-15].http://www.cde.org.cn/zdyz.do?method=largePage&id=243.