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作 者:严振 YAN Zhen(Guangdong Provincial Medical Products Administration,Guangzhou,Guangdong,China 510080)
出 处:《中国药业》2025年第8期1-7,共7页China Pharmaceuticals
摘 要:目的探讨药品智慧监管在促进“三医”(医疗、医保、医药)协同发展和治理中的作用。方法通过广东省智慧监管技术的应用实例,总结取得的成绩,并提出发展目标。结果与结论广东省通过制定高质量发展行动方案,完善了产业发展协同机制。通过优化产品结构、集聚产业资源、营造环境等措施,构建湾区药械中心联动体系;加快科研成果转化和医疗器械创新产品在广东的落地,促进区域协同,并为产业发展提供人才保障。通过深化“放管服”改革与审评审批制度改革,在提升效率的同时保障了药械质量。通过设立“岭南名方”遴选机制,以名方带动研发,构建“名医-名方-名药”的中药创新发展新路径,推动中药新药研发,从而提升产业的创新能力。通过出台相关政策,加速形成与港澳医药产业互补互动的产业链条,推动粤港澳大湾区药械监管数据共享与国际合作。通过建设省智慧药监一体化平台,构建了19个药品监管业务应用,实现了药品、医疗器械、化妆品全品类、全业务、全流程数据资源的汇聚与共享。未来广东省应以强化智慧监管的“三医”协同,推进药品追溯码医保监管与应用、县域医共体中心药房建设,推广岭南名方,促进中药发展,提升药学服务能力为目标,以促进省局药品监管现代化再上新台阶。Objective To explore the role of drug intelligent supervision in promoting the coordinated development and governance of"Three-Medical"(medical care,medical insurance,and medicine).Methods To summarize the achievements and propose development goals through the application examples of intelligent supervision technology in Guangdong Province.Results and Conclusion Guangdong Province has improved the industrial development coordination mechanism by formulating high-quality development action plans.Through measures such as optimizing the product structure,gathering industrial resources,creating an environment,to construct the linkage system of the Bay Area Pharmaceutical Equipment Center.Accelerate the transformation of scientific research results and the landing of innovative medical device products in Guangdong Province,provide talent guarantee for industrial development.By deepening the reform of"Streamlining Administration,Delegating Powers,and Improving Services"as well as the drug and medical review and approval system,efficiency has been improved while ensuring the quality of pharmaceuticals and medical devices.Through the establishment of the selection mechanism of"Lingnan Famous Preparations"and the promotion of research and development by famous prescription,a new path of innovative development of traditional Chinese medicine of"Famous Doctor-Famous Prescription-Famous Medicine"was constructed to promote the research and development of new traditional Chinese medicine and enhance the innovation ability of the industry.Through the introduction of relevant policies,to accelerate the formation of an industrial chain that complements and interacts with the Hong Kong and Macao pharmaceutical industry,and promote the sharing of drug regulatory data and international cooperation in the Guangdong-Hong Kong-Macao Greater Bay Area.Through the construction of the provincial intelligent drug supervision integration platform,19 drug supervision business applications have been established,and the convergence and sharing
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