关键词: 药品上市许可持有人, 质量管理体系, 药品监管

Abstract: 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.

Key words: Marketing authorization holder, Quality management system, Drug regulation