山东省药品研发质量管理体系问题及对策  

Problems and Countermeasures in the Drug Research and Development Quality Management System in Shandong Province

作　　者：李德宝 姜晓飞 周冲 董爱梅 LI Debao;JIANG Xiaofei;ZHOU Chong;Dong Aimei(Shandong Center For Food and Drug Evaluation&Inspection,Shandong Jinan 250100)

机构地区：[1]山东省食品药品审评查验中心,山东济南250100

出　　处：《中国质量》2025年第2期95-100,共6页China Quality

摘　　要：本文对山东省药品研制机构的药品研发质量体系现状进行分析,重点探讨各机构在质量体系建设和运行中存在的问题和难点。针对质量体系建设和运行中存在的问题,本文提出了相应的改进措施和建议,为各药品研制机构加强质量体系建设、提高药品研发质量提供了参考。同时,为山东省药品研制机构建立适宜的药品研发质量体系提供参考,为不同层级相关法规、规范性文件的制定提供指导。The article analyzes the current status of drug research and development quality system in drug research institutions in Shandong Province,with a focus on exploring the problems and difficulties that exist in the construction and operation of quality systems in each institution.The article proposes corresponding improvement measures and suggestions for the construction and operation of quality systems,providing reference for various drug development institutions to strengthen quality system construction and improve the quality of drug research and development.The article provides reference for the establishment of a suitable drug research and development quality system for drug research institutions in Shandong province,and provides guidance for the formulation of relevant regulations and normative documents at different levels.

关 键 词：山东省药品研制机构 药品研发质量体系 问题和难点 改进措施和建议 

分 类 号：F203[经济管理—国民经济]