摘要
目的:总结我国新药中化学药品生产批准上市申请法规制度的历史演变过程及现状情况,为建立更加完善的审批制度提供借鉴。方法:通过厘清我国新药上市申请审批相关制度法规的演变脉络,并结合当前的审批体系,全方位地分析该项审批制度从粗放式的行政管理逐步过度到科学法制化管理的发展轨迹。结果与结论:当前新药上市审批政策的红利已显现,同时,其不断完善的过程也会为搭建符合中国国情及接轨国际标准的监管体系奠定基础。
Objective： To review the historical evolution and current situation of approval system for marketing application of new chemical pharmaceuticals in China to provide reference for the establishment of more perfect approval system. Methods： Through clearing up the historical evolution of approval regulations for marketing application and combining with the current approval system,the development track of the regulatory system from the vulgar administration gradually transferring to the scientific management was analyzed comprehensively. Results and Conclusion： The dividend of current approval system has appeared,meanwhile,the constantly improving process will lay the foundation for setting up the regulatory system conforming to the situation of China and in line with international standards.
出处
《中国药师》
CAS
2018年第2期314-317,共4页
China Pharmacist
关键词
新药
上市
审批制度
演变
现状
New pharmaceuticals
Marketing
Approval system
Evolution
Current situation
