安徽省药品上市许可持有人质量管理体系调研分析

Investigation and Analysis of the Quality Management System of Marketing Authorization Holders in Anhui Province

目的:通过调研安徽省内药品上市许可持有人企业(仅持有B类药品生产许可证)质量管理体系的运行现状和存在问题,以期为药品上市许可持有人提出质量管理方面的改进建议,并为监管机构制定监管对策提供参考。方法:以安徽省内仅持有B类药品生产许可证的药品上市许可持有人企业作为调查对象,对其质量管理体系情况进行问卷调查,并结合现场检查发现的问题进行分析与研究。结果:本研究调研结果显示,药品上市许可持有人企业存在质量管理人员数量、工作经验与质量管理需求不匹配,与受托生产企业的质量管理体系不能有效衔接等问题。结论:本研究对优化药品上市许可持有人质量管理体系建设提出了合理化建议。药品上市许可持有人企业应健全质量管理体系,加强对受托生产企业的审核和管理,规范委托生产质量协议并建立沟通机制,持续强化药品质量管理主体责任;药品监管部门应基于风险对药品上市许可持有人企业进行分级分类管理,加强不同地区药品监管部门间的协作配合,提升监管业务能力,优化审批流程。

Objective:Through the investigation of understand the current situation and existing problems of the quality management system of marketing authorization holder(only holding Class B drug production license)in Anhui province,in order to provide suggestions for improving quality management for marketing authorization holders and assist regulatory agencies in formulating regulatory strategies.Methods:A questionnaire survey was conducted on the quality management system of marketing authorization holders that only hold Class B drug production licenses in Anhui province,and the problems found during on-site inspection of drug production were analyzed and studied.Results:The results of this survey show that the number of quality management personnel and work experience of the marketing authorization holders enterprise cannot meet the quality management needs and cannot effectively connect with the quality management system of the entrusted production enterprise.Conclusion:This study provides reasonable suggestions for optimizing the quality management system construction of drug marketing license holders.Marketing authorization holders should establish a sound quality management system,strengthen the audit and management of entrusted production enterprises,improve the quality agreement for commissioned production and establish a communication mechanism,continuously strengthening the main responsibility of drug quality management.Drug regulatory authorities should classify and manage marketing authorization holder based on risk,strengthen collaboration between drug regulatory authorities in different regions,enhance supervise capability and optimize approval process.