摘要
目的:探讨在新版《药品注册管理办法》等系列法规及技术要求下更科学、高效开展药品注册核查工作的方法,为我国药品注册核查高质量发展提供参考。方法:通过梳理我国药品注册核查的发展历程和新法规下药品注册核查的新变化,剖析新形势下我国药品注册核查工作面临的挑战,探讨应对策略。结果:新法规下药品注册核查发生变化,包括实施主体调整为由国家药品监督管理局食品药品审核查验中心统一组织开展,核查启动模式由“逢审必查”调整为“基于风险”启动,核查流程由“串联”模式调整为“并联”模式,核查组织形式由国家药品监督管理局和省、自治区、直辖市药品监督管理部门分别组织开展调整为联合核查、设立药品审评检查分中心和特殊药品检查中心等。新形势下,药品注册核查存在启动程序、核查流程不够细化,检查员队伍建设需要加强,沟通交流和风险关注点的识别、传递、控制机制需要完善,申请人注册申报质量和风险管理意识有待提升等方面的挑战。结论:建议监管机构进一步细化注册核查启动程序、核查流程及核查组织形式;持续加强检查员队伍建设,提升检查员专业水平;构建风险识别、传递和控制的闭环管理。同时建议药品注册申请人增强第一责任人意识,提升药品研发申报质量和风险管理意识,积极配合注册核查工作,提升核心竞争力,最终达到提升我国药品注册核查综合实力的目的。
Objective:To explore more scientific and efficient methods for conducting drug pre-approval inspection under newly-revised Provisions for Drug Registration and other series of regulations and technical requirements,provide reference for the high-quality development of drug pre-approval inspection in China.Methods:By reviewing the development history of drug pre-approval inspection in China and the new changes in drug pre-approval inspection under new regulations,this study analyzes the challenges faced by drug pre-approval inspection in China under the new situation and explores corresponding strategies.Results:Under the new regulations,there have been changes in drug pre-approval inspection,including the work to be organized and carried out by CFDI,initiation mode adjusted from mandatory inspections to risk-based initiation,inspection procedure adjusted from series to parallel,organizational form adjusted from organized by NMPA and drug administration of province respectively to joint inspection,establish evaluation and inspection sub-centers,and special drug inspection center;under the new situation,drug inspection faces challenges in initiation program and procedure of inspection,construction of inspector team,collaboration and risk transmission mechanisms,applicant’s registration quality and risk management awareness.Conclusion:It is recommended that regulatory agencies further refine initiation program and procedure of inspection,improve effective communication mechanisms and form a closed-loop management system for risk identification,transmission,and control,strengthen the construction of the inspector team and enhance the professional level of inspectors.At the same time,it is recommended that drug registration applicants should enhance the awareness of the first person in charge,improve quality of drug research and development application and risk awareness,actively cooperate with the work of inspection and strengthen the key competitiveness.The ultimate goal is to enhance the comprehensive strength of drug pre-approval inspection in China.
作者
史海涛
黄晓龙
成斌
杨敬鹏
何本霞
Shi Haitao;Huang Xiaolong;Cheng Bin;Yang Jingpeng;He Benxia(Guangdong-Hong Kong-Macao Greater Bay Area Center for Drug Evaluation and Inspection of NMPA,Shenzhen 518000,China;Center for Food and Drug Inspection of NMPA,Beijing 100044,China)
出处
《中国药事》
2025年第3期243-252,共10页
Chinese Pharmaceutical Affairs
关键词
药品注册核查
新变化
挑战
闭环管理
核心竞争力
drug pre-approval inspection
new changes
challenges
closed-loop management
key competitiveness
