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化学创新药不同注册申请阶段沟通交流中的药学问题一般性考虑

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目的:进一步提高化学创新药沟通交流质量和效率,加大创新药研发支持力度,强化对申请人的技术指导和服务.方法:结合创新药不同注册申请阶段药学相关技术指南和审评实际,就相关沟通交流中药学部分存在的问题提出建议.结果 与结论:针对化学创新药不同注册申请阶段沟通交流中的常见问题提出解决路径及关注要点,希望能为药品注册申请人提供借鉴,同时提升沟通的质量和效率,更好地服务于药品创新与发展.
General Considerations for Pharmaceutical Issues in the Communication of Innovative Chemical Drug at Different Application Stages for Registration
Objective:To further improve the quality and efficiency of communication on innovative chemical drugs,and to increase support for innovative drug research and development,as well as strengthen technical guidance and services for applicants. Methods:Based on the relevant technical guidelines and review practices of pharmaceutical at different application stages of innovative drugs for registration,this paper puts forward suggestions on the pharmaceutical problems existing in relevant communication. Results and Conclusion:Solutions and focus points for the common problems in the communication of innovative chemical drug at different application stages for registration are proposed,hoping to provide references for drug registration applicants,improve the quality and efficiency of communication,and better serve drug innovation and development.

chemical drugsinnovative drugscommunicationreview

任峰、姜涛、陈爱萍、刘涓、任连杰、范乙

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国家药品监督管理局药品审评检查长三角分中心,上海 201210

国家药品监督管理局药品审评中心,北京 100076

化学药品 创新药 沟通交流 审评

2024

中国药事
中国食品药品检定研究院(中国药品生物制品检定所)

中国药事

CSTPCD
影响因子:0.844
ISSN:1002-7777
年,卷(期):2024.38(12)