摘要
自2006年世界上首支人乳头瘤病毒(HPV)疫苗注册上市以来,多家国内企业开始了HPV疫苗的研发及申报工作。为引导HPV疫苗的良性有序研发和申报,加强申报前的研究,提高申报资料的质量,本文对目前在我国已上市的HPV疫苗,处于上市注册申请阶段、临床试验阶段、临床试验申请阶段的HPV疫苗进行了梳理,并对其申报资料中存在的药学问题进行了汇总,此外对HPV疫苗公开研讨会形成的药学共识进行了归纳。
Since the first human papillomavirus( HPV) vaccine was licensed in 2006,many domestic enterprises have started the research and submission of HPV vaccines. In order to guide and enhance the research before submission and improve the quality of application dossier,this paper collected related information of HPV vaccines which is currently on the market in China and in the stages of investigational new drug( IND),clinical trial and new drug application( NDA). In addition,the pharmaceutical problems and defects in their application dossier are summarized. Comments and recommends from academic workshop on HVP vaccine development are collected for attention as well.
作者
任慧梅
李敏
罗建辉
REN Hui-mei;LI Min;LUO Jian-hui(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2020年第21期2465-2469,共5页
Chinese Journal of New Drugs
关键词
人乳头瘤病毒疫苗
申报现状
药学研发思考
human papillomavirus vaccine
submission status
considerations for pharmaceutical researches
