我国实施ICH M系列技术指导原则的策略研究
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摘要
通过对ICH M系列指导原则与我国相关技术指导原则的对比研究,分析我国相关技术指导原则与ICH M系列指导原则的主要差异。通过对公众、专家、企业进行问卷调查,摸清了ICHM系列指导原则在我国的认知和实施基础。在对比研究和问卷调查的基础上,结合ICH的要求,提出了ICH M系列指导原则在我国实施的建议。
Through the comparative study of ICH Multidisciplinary Guidelines and corresponding Chinese technical guidelines, the main differences in Multidisciplinary Guidelines for drug registration between China and ICH are analyzed. Through questionnaire survey to the public, experts and enterprises, the cognition and implementation basis of ICH Multidisciplinary Guidelines in China are found out. On the basis of comparative study and questionnaire survey, combined with the requirements of ICH, the implementation proposals of ICH Multidisciplinary Guidelines in China are put forward in this paper.
Through the comparative study of ICH Multidisciplinary Guidelines and corresponding Chinese technical guidelines, the main differences in Multidisciplinary Guidelines for drug registration between China and ICH are analyzed. Through questionnaire survey to the public, experts and enterprises, the cognition and implementation basis of ICH Multidisciplinary Guidelines in China are found out. On the basis of comparative study and questionnaire survey, combined with the requirements of ICH, the implementation proposals of ICH Multidisciplinary Guidelines in China are put forward in this paper.
引文
[1]陈震,杨建红,韩鹏,等.我国实施ICH Q系列技术指导原则的策略研究[J].现代药物与临床,2018,33(4):981-988.
[2]杨建红,韩鹏,张彦彦,等.我国实施ICH S系列技术指导原则的策略研究[J].现代药物与临床,2018,33(7):1843-1847.
[3]陈震,胡蓓,杨建红,等.我国实施ICH E系列技术指导原则的策略研究[J].现代药物与临床,2018,33(9):2455-2460.
[4]Multidisciplinary Guidelines[EB/OL].[2018-09-03].http://www.ich.org/products/guidelines/multidisciplinary/article/multidisciplinary-guidelines.html.
[5]ICH.Rules of Procedure of the Assembly[EB/OL].(2017-05-31).http://www.ich.org/fileadmin/Public_Web_Site/ABOUT_ICH/Articles_Procedures/ICH_Assembly_Ro Ps_31May2017.pdf.
[6]ICH.Medical Dictionary for Regulatory Activities(M1Med DRA)[EB/OL].(2016-11-06).http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Mu ltidisciplinary/M1/M1_Pt C_Concept_Paper_final_6Nov2016.pdf.
[7]ICH.The Common Technical Document(M4)[EB/OL].(2003-07).http://www.ich.org/products/ctd.html.
[8]M4:The Common Technical Document[EB/OL].[2018-09-03].www.ich.org/products/ctd.html.
[9]国家食品药品监督管理总局.关于按CTD格式撰写化学药品注册申报资料有关事项的通知(国食药监注
[2010]387号)[EB/OL].(2010-09-25).http://www.sda.gov.cn/WS01/CL0844/54391.html.
[10]国家食品药品监督管理总局.总局关于发布化学药品新注册分类申报资料要求(试行)的通告(2016年第80号)[EB/OL].(2016-05-04).http://www.sda.gov.cn/WS01/CL0087/151985.html.
[11]ICH.Electronic Common Technical Document(e CTD)(M8)[EB/OL].(2010-11-08).http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M8/M8_e CTD_Concept_Paper.pdf.
[12]国家食品药品监督管理总局.关于印发化学药药学资料CTD格式电子文档标准(试行)和药品注册申报资料的体例与整理规范的通知(食药监办注[2011]98号)[EB/OL].(2011-06-27).http://www.sda.gov.cn/WS01/CL0844/63576.html.
[13]国家食品药品监督管理总局.总局关于适用国际人用药品注册技术协调会二级指导原则的公告(2018年第10号)[EB/OL].(2018-01-25).http://samr.cfda.gov.cn/WS01/CL0087/223345.html.
[2]杨建红,韩鹏,张彦彦,等.我国实施ICH S系列技术指导原则的策略研究[J].现代药物与临床,2018,33(7):1843-1847.
[3]陈震,胡蓓,杨建红,等.我国实施ICH E系列技术指导原则的策略研究[J].现代药物与临床,2018,33(9):2455-2460.
[4]Multidisciplinary Guidelines[EB/OL].[2018-09-03].http://www.ich.org/products/guidelines/multidisciplinary/article/multidisciplinary-guidelines.html.
[5]ICH.Rules of Procedure of the Assembly[EB/OL].(2017-05-31).http://www.ich.org/fileadmin/Public_Web_Site/ABOUT_ICH/Articles_Procedures/ICH_Assembly_Ro Ps_31May2017.pdf.
[6]ICH.Medical Dictionary for Regulatory Activities(M1Med DRA)[EB/OL].(2016-11-06).http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Mu ltidisciplinary/M1/M1_Pt C_Concept_Paper_final_6Nov2016.pdf.
[7]ICH.The Common Technical Document(M4)[EB/OL].(2003-07).http://www.ich.org/products/ctd.html.
[8]M4:The Common Technical Document[EB/OL].[2018-09-03].www.ich.org/products/ctd.html.
[9]国家食品药品监督管理总局.关于按CTD格式撰写化学药品注册申报资料有关事项的通知(国食药监注
[2010]387号)[EB/OL].(2010-09-25).http://www.sda.gov.cn/WS01/CL0844/54391.html.
[10]国家食品药品监督管理总局.总局关于发布化学药品新注册分类申报资料要求(试行)的通告(2016年第80号)[EB/OL].(2016-05-04).http://www.sda.gov.cn/WS01/CL0087/151985.html.
[11]ICH.Electronic Common Technical Document(e CTD)(M8)[EB/OL].(2010-11-08).http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M8/M8_e CTD_Concept_Paper.pdf.
[12]国家食品药品监督管理总局.关于印发化学药药学资料CTD格式电子文档标准(试行)和药品注册申报资料的体例与整理规范的通知(食药监办注[2011]98号)[EB/OL].(2011-06-27).http://www.sda.gov.cn/WS01/CL0844/63576.html.
[13]国家食品药品监督管理总局.总局关于适用国际人用药品注册技术协调会二级指导原则的公告(2018年第10号)[EB/OL].(2018-01-25).http://samr.cfda.gov.cn/WS01/CL0087/223345.html.