以皮肤科药物为例谈我国药物研发沟通交流制度的改革与思考  

Rationale of communication system reform in new drug development illustrated by drugs for skin diseases

作　　者：徐鹏遥 翟云 葛玉梅 赵聪 钱思源 谢松梅 XU Peng-yao;ZHAI Yun;GE Yu-mei;ZHAO Cong;QIAN Si-yuan;XIE Song-mei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国新药杂志》2023年第19期1941-1945,共5页Chinese Journal of New Drugs

摘　　要：目的:以皮肤科药物创新为例,探讨研发期间注册申请人与监管机构间沟通交流中发现的一些常见临床研发问题,进行总结和分析解答,以期为同类咨询问题的解决提供参考,指导规范沟通交流申请的质量,提高沟通交流和审评效率。方法:梳理国家药品监督管理局药品审评中心接收到的皮肤科药物各类沟通交流申请情况、临床研发相关咨询问题并进行分类,对共性问题分析总结,阐述监管考虑。结果与结论:沟通交流制度的不断完善可以有效促进研发与监管的互动,针对性解决更多的个性技术问题,以满足药物高效研发的需求,但沟通交流的质量和效率提高等问题需要监管机构和申请人共同努力解决。Objective:Taking the development of dermatology drugs as an example,proposals are provided after analysis by summarizing the common clinical questions about drugs development encountered in communication,in order to provide reference for the same problems and improve the efficiency and quality in communication system.Methods:The clinical improvement questions were collected and classified regarding dermatology drugs,communication applications in the communication subsystem of the Center for Drug Evaluation of National Medical Products Administration drug technical review system.The common questions were analyzed and regulatory considerations for improvement were elaborated.Results and Conclusion:Efficient communication system can promote the interaction between research and regulation,solve more individual problems,satisfy the needs in drug developments;however,developers and regulators need to work together to improve the quality and efficiency of communication.

关 键 词：沟通交流制度 药品注册 皮肤科药物 政策法规 

分 类 号：R986[医药卫生—药品]