夯实质量管理体系基础 深化审评审批制度改革

Deepen Reform of the Evaluation and Approval Regulations by Reinforcing the Foundation of Quality Management System

国务院办公厅印发《关于全面加强药品监管能力建设的实施意见》(国办发[2021]16号),提出"健全国家药品监管质量管理体系"。国家药品监督管理局坚持人民至上、生命至上,立足保安全守底线、促发展追高线,深化药品监管改革,加快推进药品监管体系和监管能力现代化。国家药品监督管理局医疗器械技术审评中心坚持以方针和目标为质量引导,以融合和互促为质量原则,以测量和评查为质量保证,以制度和尺度为质量改进,建立符合审评实际的质量管理体系,持续深化医疗器械审评审批制度改革,提供规范高效技术审评服务,并不断实践总结,逐步实现技术审评"全国一盘棋"。

Based on the new situation of drug and medical device supervision at home and abroad, NMPA put forward specific requirements for establishing and perfecting drug evaluation and approval regulations. CMDE has explored new tools for medical device supervision, actively strengthened the quality management capacity building of technical evaluation, and followed scientific management rules. By constant practice and summary, we gradually unified the national standards for technical evaluation and improved the quality of medical registration approval.