我国生物制品的注册历程分析
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摘要
自1985年至今,在生物制品发展过程中,历版重要法规和文件不断修订,包括历年版《药品注册管理办法》,也包括《中华人民共和国药典》,这是我国生物制品注册监管理念不断更新、技术评价标准不断完善的体现。在国家政策的引导下,生物制品审评审批更加严格,创新程度不断提高,低水平重复逐渐减少。本文以时间轴为顺序,结合历年获批上市的生物制品情况,分析部分重要法规修订对生物制品注册的影响。
In the development of biological products since 1985,several important regulations and documents have been issued,including the constantly revised Provisions for Drug Registration and Pharmacopoeia of the People's Republic of China,reflecting the improved regulatory ideas on registrations of biological products and stricter technical evaluation standards in China. Under the guidance of national policies,China is witnessing increasingly strict review and approval of biological products,innovative biological products,and gradually reduced low-level duplication. Herein, in chronological order, we, by taking into consideration approved biological products,analyzed the impact of some of the important regulatory revisions on the registrations of biological products.
In the development of biological products since 1985,several important regulations and documents have been issued,including the constantly revised Provisions for Drug Registration and Pharmacopoeia of the People's Republic of China,reflecting the improved regulatory ideas on registrations of biological products and stricter technical evaluation standards in China. Under the guidance of national policies,China is witnessing increasingly strict review and approval of biological products,innovative biological products,and gradually reduced low-level duplication. Herein, in chronological order, we, by taking into consideration approved biological products,analyzed the impact of some of the important regulatory revisions on the registrations of biological products.
引文
[1]佘清.我国生物制品质量控制标准的发展与现状[J].中国药事,2001,15(2):53-55.
[2]郭中平.我国疫苗质量标准的回顾与现状分析[J].中国药事,2012,26(8):795-800.
[3]郭中平. 2015新版中华人民共和国药典与中国生物医药产业发展[J].中国新药杂志,2015,24(20):2352-2356.
[4]常卫红,韩培,曹连之.中国新药研发与注册管理30年回顾与展望(一)——生物制品注册管理法规回顾与思考[J].中国新药杂志,2010,19(23):2127-2131.
[5]常卫红,韩培,曹连之.中国新药研发与注册管理30年回顾与展望(二)——生物制品审评技术要求变迁与生物药研发[J].中国新药杂志,2011,20(3):208-212.
[6]胡方远.生物制品的历史回顾——为2000年版中国药典出版[J].中国药品标准,2001,2(1):22-26.
[7]郭中平.实施《中国药典》2010年版三部完善生物制品质量控制[J].中国药事,2010,24(7):627-630.
[8]国家食品药品监督管理总局药品审评中心. 2016年度药品审评报告[EB/OL].[2017-03-17]. http://www. cde. org.cn/news. do? method=large Info&id=313842.
[9]国家食品药品监督管理总局药品审评中心. 2017年度药品审评报告[EB/OL].[2018-03-23]. http://www. cde. org.cn/news. do? method=large Info&id=314402.
[10]周爱萍.生物治疗药物和生物类似药研究进展[J].中国新药杂志,2017,26(3):296-299.
[2]郭中平.我国疫苗质量标准的回顾与现状分析[J].中国药事,2012,26(8):795-800.
[3]郭中平. 2015新版中华人民共和国药典与中国生物医药产业发展[J].中国新药杂志,2015,24(20):2352-2356.
[4]常卫红,韩培,曹连之.中国新药研发与注册管理30年回顾与展望(一)——生物制品注册管理法规回顾与思考[J].中国新药杂志,2010,19(23):2127-2131.
[5]常卫红,韩培,曹连之.中国新药研发与注册管理30年回顾与展望(二)——生物制品审评技术要求变迁与生物药研发[J].中国新药杂志,2011,20(3):208-212.
[6]胡方远.生物制品的历史回顾——为2000年版中国药典出版[J].中国药品标准,2001,2(1):22-26.
[7]郭中平.实施《中国药典》2010年版三部完善生物制品质量控制[J].中国药事,2010,24(7):627-630.
[8]国家食品药品监督管理总局药品审评中心. 2016年度药品审评报告[EB/OL].[2017-03-17]. http://www. cde. org.cn/news. do? method=large Info&id=313842.
[9]国家食品药品监督管理总局药品审评中心. 2017年度药品审评报告[EB/OL].[2018-03-23]. http://www. cde. org.cn/news. do? method=large Info&id=314402.
[10]周爱萍.生物治疗药物和生物类似药研究进展[J].中国新药杂志,2017,26(3):296-299.