海南省仿制药一致性评价品种分析与工作进展
|
摘要
仿制药一致性评价是指对已经批准上市的仿制药,按与原研药品质量和疗效一致的原则,分期分批进行的质量评价。为促进海南省仿制药一致性评价工作的顺利开展,通过检索海南省药品注册文号信息系统(琼兰档案管理系统),梳理了海南省已获批药品中涉及须通过仿制药一致性评价的品种目录以及相关品种在类别、数量、构成等方面的数据,并调研企业面临的困难及工作进展,为海南省涉及一致性评价的相关企业与部门提供参考,为海南省制定生物医药产业创新发展政策提供了数据支持。
Consistency evaluation of generic drugs quality and efficacy means evaluating the quality of generic drugs that have been approved for listing according to the same principle as the quality and curative effect of the original drug partially and in blocks.In order to promote consistency evaluation of generic drugs in Hainan province,the data related to the category,number and distribution of generic drugs manufactured in Hainan which are required to pass consistency evaluation were collected from the information management system of Drug approval number in Hainan( Qionglan file-management system).Meanwhile,the difficulties that enterprises faced and work process were investigated.This work has offered references for the enterprises and departments involved in consistency evaluation of generic drugs,and also provided data supports for the innovation of bio-pharmaceutical development policies in Hainan Province.
Consistency evaluation of generic drugs quality and efficacy means evaluating the quality of generic drugs that have been approved for listing according to the same principle as the quality and curative effect of the original drug partially and in blocks.In order to promote consistency evaluation of generic drugs in Hainan province,the data related to the category,number and distribution of generic drugs manufactured in Hainan which are required to pass consistency evaluation were collected from the information management system of Drug approval number in Hainan( Qionglan file-management system).Meanwhile,the difficulties that enterprises faced and work process were investigated.This work has offered references for the enterprises and departments involved in consistency evaluation of generic drugs,and also provided data supports for the innovation of bio-pharmaceutical development policies in Hainan Province.
引文
[1]向金莲.开展仿制药质量一致性评价的现状和意义[J].中国药物经济学,2017,12(7):17-18.
[2]梁支燕,黎惠柔,汤丹,等.广东省仿制药一致性评价品种分析与工作展望[J].药学进展,2017,41(9):689-695.
[3]胡林峰,虞忠.仿制药一致性评价的产业影响研究[J].中国医药工业杂志,2016,47(8):1097-1101.
[4]冯昊,潘悦,雷霆,等.北京市开展仿制药一致性评价的实践及进展[J].中国医药工业杂志,2017,48(12):1807-1817.
[5]张立颖,刘旭亮,张丽宝.浅析仿制药一致性评价程序及内容的相关政策[J].药学研究,2017,36(5):305-307.
[6]国家食品药品监督管理总局.总局关于落实《国务院办公厅关于开展仿制药质量和疗效一致性评价的意见》有关事项的公告(2016年第106号)[EB/OL].[2016-05-26]. http://samr. cfda. gov. cn/WS01/CL1757/154042.html.
[7]国家食品药品监督管理总局.总局关于发布通过仿制药质量和疗效一致性评价药品的公告(第一批)(2017年第173号)[EB/OL].[2017-12-28]. http://samr.cfda.gov.cn/WS01/CL0087/220787.html.
[8]国家药品监督管理局.国家药品监督管理局关于蒙脱石散等16个品种通过仿制药质量和疗效一致性评价的公告(第五批)(2018年第49号)[EB/OL].[2018-7-23]. http://www. nmpa. gov. cn/WS04/CL2182/329691.html.
[2]梁支燕,黎惠柔,汤丹,等.广东省仿制药一致性评价品种分析与工作展望[J].药学进展,2017,41(9):689-695.
[3]胡林峰,虞忠.仿制药一致性评价的产业影响研究[J].中国医药工业杂志,2016,47(8):1097-1101.
[4]冯昊,潘悦,雷霆,等.北京市开展仿制药一致性评价的实践及进展[J].中国医药工业杂志,2017,48(12):1807-1817.
[5]张立颖,刘旭亮,张丽宝.浅析仿制药一致性评价程序及内容的相关政策[J].药学研究,2017,36(5):305-307.
[6]国家食品药品监督管理总局.总局关于落实《国务院办公厅关于开展仿制药质量和疗效一致性评价的意见》有关事项的公告(2016年第106号)[EB/OL].[2016-05-26]. http://samr. cfda. gov. cn/WS01/CL1757/154042.html.
[7]国家食品药品监督管理总局.总局关于发布通过仿制药质量和疗效一致性评价药品的公告(第一批)(2017年第173号)[EB/OL].[2017-12-28]. http://samr.cfda.gov.cn/WS01/CL0087/220787.html.
[8]国家药品监督管理局.国家药品监督管理局关于蒙脱石散等16个品种通过仿制药质量和疗效一致性评价的公告(第五批)(2018年第49号)[EB/OL].[2018-7-23]. http://www. nmpa. gov. cn/WS04/CL2182/329691.html.