药品注册程序中争议解决机制优化的初步考虑

Preliminary considerations on optimizing the dispute resolution path of drug registration procedure

摘要

药品注册行政许可的合法性与确定性是国家药品监管体系现代化的核心标志。在药品注册多环节、多部门共同参与的背景下,实现药品注册申请人的陈述申辩权与维护行政效率之间的平衡尤为重要。本文梳理当前药品注册环节中涉及的争议解决机制,分析在程序衔接、结论效力认定上的模糊地带以及对行政许可决定的科学性和权威性带来的挑战,从立法、制度和程序层面提出完善我国药品注册争议解决机制的初步建议,以期为构建权责清晰、程序公正、衔接顺畅、运行高效的药品注册争议解决机制提供参考。

Abstract

The legality and certainty of administrative licensing for drug registration are core symbols of the modernization of the country's drug regulatory system.In the context of multiple links and departments participating in drug registration,it is particularly important to balance the right to statement and defense of drug registration applicants with the maintenance of administrative efficiency.This paper sorted out the dispute resolution mechanisms involved in the current drug registration process,analyzed the ambiguous areas in procedure connection and determination of the effect of conclusions,as well as the challenges they pose to the scientificity and authority of administrative licensing decisions.It also proposed preliminary suggestions to improve China's drug registration dispute resolution mechanism from the legislative,institutional and procedural levels,aiming to provide references for building a drug registration dispute resolution mechanism with clear power and responsibilities,fair procedures, smooth connection and efficient operation.

关键词

药品注册 / 争议解决 / 行政权力 / 正当法律程序 / 程序正义 / 行政效率

Key words

drug registration / dispute resolution / administrative rights / due legal process / procedural justice / administrative efficiency

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