部分国家健康产品监管部门体制变迁及机构设置初探

Exploration of regulatory reform and organization structure in foreign health product supervision authorities

健康产品具有特殊属性,统一监管能够最大限度地整合监管资源,减缓信息不对称,提高监管效能。美国、韩国、泰国健康产品安全监管体制改革呈现分散到统一的发展历程,跨品种、跨环节、跨部门的健康产品安全监管职能和资源逐步纳入统一监管部门。改革历程呈现出积极稳步推进、因地因时制宜、以法律为保障等特点。目前,上述国家健康产品安全监管部门的机构设置系统、综合,目标一致、资源共享、行动协调,有效地提高了行政执行效率和健康产品安全保障水平。我国健康产品安全监管正逐步实现组织结构上的整合,国外有关机构和组织的改革历程和运行经验可为我国健康产品安全监管体系的不断完善提供一定参考。

Unified health product supervision system can maximize the integration of regulation resources, reduce information asymmetry, and improve regulation efficiency, since health products have special properties which are different from ordinary products. The regulatory reform of healthy products showed a process from decentralization to unification in United States, Korea, and Thailand. Health product supervision functions and resources crossing species, links, and sections were integrated gradually into a unified supervision depart-ment and regulatory reforms proceeded from reality, advanced step by step orderly, and followed a legal track. The present organization structures of these health products supervision authorities are synthetic and compre-hensive. By using unified healthy products supervision system, the administrative efficiency and health product safety had been improved. Their processes of regulatory reform could provide valuable reference for establish-ing health product supervision system in China.