| 徐大丽,章文霞.上市许可持有人制度实施以来我国药品监管现状探究[J].中国药事,2023,(8):857-863 |
| 上市许可持有人制度实施以来我国药品监管现状探究 |
| Exploration on the Current Situation of Drug Regulation in China Since the Implementation of Marketing Authorization Holder System |
| 投稿时间：2023-04-18 |
| DOI：10.16153/j.1002-7777.2023.08.001 |
| 中文关键词: 药品上市许可持有人制度 审评审批 药品监管 高质量发展 建议 |
| 英文关键词: drug marketing authorization holder system review and approval drug regulation high quality development propose |
| 基金项目:甘肃省药品科研项目资助（编号 2022GSMPA0054） |
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| 摘要点击次数: 1078 |
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| 中文摘要: |
| 目的：促进药品上市许可持有人（MAH）制度在我国持续发展，为医药行业高质量发展提供借鉴。方法：系统梳理药品MAH制度实施以来，2020-2022年全国药品申请及抽样的相关数据，并随机抽取150家药品生产企业现场检查相关数据，汇总药品MAH质量管理现状及存在问题，分析总结药品MAH 制度对我国药品创新、审评审批及质量监管等重点环节带来的影响，提出参考性建议。结果与结论：药品MAH制度在激发药品创新积极性、优化行业资源配置方面已初见成效，建议持续强化药品MAH主体责任，全面提高药品监管能力，提升检查员整体素质，持续深化药品审评审批制度改革，构筑符合中国国情的药品MAH制度。 |
| 英文摘要: |
| Objective: To promote the sustainable development of the drug marketing authorization holder (MAH) system in China, and provide references for the high-quality development of the pharmaceutical industry. Methods: Relevant data on national drug applications and sampling from 2020 to 2022 since the implementation of the drug MAH system was systematically sorted out, and relevant data of on-site inspection from 150 drug manufacturing enterprises were randomly selected. Current situation and existing problems of drug MAH quality management were analyzed and the impact of the drug MAH system on key links such as drug innovation, review and approval, and quality supervision in China was summarized. Finally, the reference suggestions were proposed. Results and Conclusion: The drug MAH system has achieved initial results in stimulating the enthusiasm for drug innovation and optimizing the allocation of industry resources. It is recommended to continuously strengthen the main responsibility of the drug MAH, comprehensively improve drug regulatory capacity, improve the overall quality of inspectors, continue to deepen the reform of the drug review and approval system, and build a drug MAH system that conforms to China's national conditions. |
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