新法规背景下境内药品再注册的技术审查标准研究

Study on Technical Review Standard of the Re-registration of the Domestic Drugs Under the Background of New Regulations

摘要: 目的构建新药品注册法规背景下境内药品再注册的技术审查标准。方法通过分析药品法规和审查案例，初步确立境内药品再注册的审查要素，并采用改进德尔菲专家函询法，对33名药品注册审查专家进行2轮函询，统计分析函询结果。结果制定了一套境内药品再注册的技术审查标准，包括8个一级要素、41个二级要素。结论本研究构建的技术审查标准有望促进药品再注册技术审查工作的规范化，提升药品再注册技术审查质量。

Abstract: OBJECTIVE To establish technical review standard of the re-registration of the domestic drugs under the background of new regulations. METHODS Through the analysis of drug laws and regulations and review cases, the review elements of the re-registration of the domestic drugs were preliminarily established, and the improved Delphi expert consultation method was used to conduct two rounds of consultation on 33 drug registration review experts, and the consultation results were statistically analyzed. RESULTS A set of technical review criteria for the re-registration of the domestic drugs was developed, including 8 first-level elements and 41 second-level elements.CONCLUSION The technical review standards constructed in this study are expected to promote the standardization of drug re-registration technical review and improve the quality of drug re-registration technical review.