国际人类辅助生殖技术监督与质量管理模式

International supervision and quality management of human assisted reproductive technology

随着辅助生殖技术(ART)在我国的迅猛发展,其安全性、有效性以及涉及的伦理、法律问题日益引人关注。全球ART的监管主要有3条路径:通过政府建立权威的归口管理机构,制定法律法规监管路径;非官方的行业协会自身监管路径;ART中心通过不断改进质量管理体系,完善自身质量管理的路径。对ART的系统管理,可确保ART中心的良性发展,从而保障公众和不孕夫妇的利益。本文对国际上各层级ART的监管体系的形成和特点进行分析,以供参考。

With the rapid development of assisted reproductive technology （ART） in China, its safety, effectiveness, ethics and laws involved are receiving more and more attention. There are three main paths for the global regulation of ART： the establishment of an authoritative and centralized management institution through the government regulatory path; unofficial industry association＇s regulatory path; quality management system established by ART Centers. System management of ART ensures the healthy development of the ART Center, and protects the interests of the public and infertile couples. This paper analyzes the formation and characteristics of the international ART＇s regulatory system for reference.