英国药品与医疗保健用品监管机构变迁

Evolution of medicines and healthcare products regulatory agency

本文从法律基础、机构设置、人员配置和财源配置、执法责任、治理架构的角度,分析英国药品与医疗保健用品监管机构变迁及监管资源配置。在法律基础方面,实时调整法律法规,将欧盟指令等纳入相关法律法规中。在机构设置方面,针对监管对象变化和科学技术方面的进步不断做出调整,发挥机构内部不同部门的协同效应,确保药品和器械有效和安全,增强和保障公众健康,改善患者医疗保健并使英国在相关的科学研究领域保持全球领先地位。在质量保证、安全性与监管方面,为企业提供一站式服务。为研发提供以科学为导引的监管;促进创新,使创新产品安全上市。实现更好的公众健康的药物警戒和风险管理综合路径。财政上,以政府运营基金的形式运营。MHRA属于执行机构,与在法律和宪法上与部委控制相独立的非部委政府部门和非部委公共机构存在显著不同的政府机构。药品和医疗器械监管职能和执法集中于MHRA。来自于行业的付费占MHRA经费投入的绝大部分。人员配置的重点和付费、支出、盈余的占比,反映MHRA的重点放在注册批准、药物警戒、检查、器械、临床规范研究数据关联方面。英国药品与医疗器械监管体系,为其他国家相关领域深化体制改革提供了参考与借鉴,

The evolution of Medicines and Heahhcare products Regulatory Agency （MHRA） , and the relevant resource allocation are analyzed by reviewing of the legal bases, institution setting, human resource deploying, financial structure, and governance framework of the regulator. The laws and regulations are adjusted to include the relevant EC directives. And the continuous institutional restructuring aims to keep pace with the change in the regulated area and the development of the science and technology, take the advantage of the synergistic effect of the institutions belonging to the regulator, improve the healthcare of the patients whilst keeping the leading posi- tion of UK in the relevant area, influence the development of science-led regulation, promote innovation to ensure the safety of the launch of the innovative products, and deliver better public health by integrated approach to pharmacovigilance and risk management. MHRA is an executive agency and operates as a government trading fund; the executive agency is distinct from non-ministerial government departments and non-departmental public bodies which enjoy a real legal and constitutional separation from ministerial control. The centralized regulation of medicine and medical devices is implemented in MHRA. The user fees take the majority in the financial funding of MHRA. The ratios of the human resource deployment and user fees, expenditures, and earnings reflect that the focus of MHRA is on approval, pharmacovigilance, inspection, device, and Clinical Practice Research Datalink （CPRD）. The regulatory system for medicines and medical devices of UK provides useful reference for the deepened reform in the relevant regulation in other countries.