国家药监局技术指导原则的法律属性分析

On the Legal Characteristics of NMPA’s Technical Guidelines

目的:确认国家药监局技术指导原则的文件法律属性,推动审评审批制度进一步法治化、规范化。方法:比较技术指导原则与技术标准、技术法规、行政指导、行政裁量基准、行政规范性文件等在特征上的异同,并通过文献研究探明药品技术指导原则的生成机制。结果:技术指导原则不具有强制性与正式法律效力,不属于技术标准与技术法规;但它事实上影响相关申请人的行为路径以及权利义务,涉及行政许可的条件与标准问题。此外,技术指导原则作为药品监管工具从国外移植到中国,其名词术语体系与我国法律体系尚有差别。结论:在我国行政法律体系内,技术指导原则应归属于药品审评审批的裁量基准,具有行政规范性文件的属性特征。同时建议进一步完善技术指导原则制度。

Objective:To assess the legal characteristics of NMPA’s technical guidelines and promote law-based and standardized development of the drug review&approval system.Methods:A comparative study was done to find the similarities and differences between technical guidelines,technical standards,technical regulations,administrative guidelines,administrative discretion benchmark and administrative normative documents.And the history and process of drafting drug regulatory guidelines by the US FDA were studied through literature review.Results:Technical guidelines have no legal standing,and are not considered technical standards or established regulations.However,they outline the rights and obligations of relevant applicants,and touch on the conditions and standards for administrative licenses.In addition,as a drug regulatory tool,technical guidelines,having been introduced to China from the United States,retain some characteristics of the American legal system.Conclusions:Technical guidelines within the Chinese system of administrative law should be considered as the basis for administrative discretion in the area of drug review&approval,and they share the same legal characteristics as administrative normative documents.We recommend to further standardize and improve NMPA’s guidelines.