摘要
目的:以百日咳疫苗、人用狂犬病疫苗的改良情况为例,分析监管政策对预防用生物制品技术改良的影响。方法:通过数据分析和文献研究,对我国已批准疫苗的技术改良情况进行分析。结果:技术改良是促进疫苗产业发展的重要手段。结论:监管机构需要通过政策的引导和鼓励促进疫苗的技术改良。
Objective:To review the influence of regulatory policies on technical improvement of biological products for prevention taking the improvement of pertussis vaccine and human rabies vaccine as an example.Methods:The technical improvements in approved vaccines in China were analyzed through data analysis and literature research.Results:Technical improvement is an important means to promote the development of the vaccine industry.Conclusion:Regulatory authority should promote technical improvement of vaccines through policy guidance and encouragement.
作者
刘志磊
李洁
高恩明
李小芳
杨建红
张辉
Liu Zhilei;Li Jie;Gao Enming;Li Xiaofang;Yang Jianhong;Zhang Hui(Center for Drug Evaluation,NMPA,Beijing 100038,China;Pfizer Investment Co.,Ltd.,Beijing 100010,China;New Drug Application Sevice Center of Taizhou Medical New&Hi-tech Industrial Development Zone,Taizhou 225300,China;Yeehong Business School of Shenyang Pharmaceutical University,Beijing 100027,China;National Medical Products Administration,Beijing 100037,China)
出处
《中国药事》
CAS
2020年第1期1-4,共4页
Chinese Pharmaceutical Affairs
基金
亦弘商学院组织开展的“我国生物制品产品目录分析及建立我国‘紫皮书’的必要性和可行性研究课题”,该课题由国家药品监督管理局药品注册管理司委托.
关键词
疫苗
技术改良
监管
百日咳疫苗
人用狂犬病疫苗
政策
vaccine
technical improvement
regulatory
pertussis vaccine
human rabies vaccine
policies
作者简介
刘志磊,博士,审评员,研究方向:预防用生物制品审评,Tel:(010)65541577,E-mail:1093808600@qq.com;通信作者:张辉,Tel:(010)65541577,E-mail:1093808600@qq.com
