| 佟乐.英国脱欧后药品医疗器械监管体制机制探究[J].中国药事,2021,35(12):1429-1435 |
| 英国脱欧后药品医疗器械监管体制机制探究 |
| The Exploration of Regulatory System and Mechanism of Pharmaceuticals and Medical Devices in the United Kingdom after Brexit |
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| DOI：10.16153/j.1002-7777.2021.12.015 |
| 中文关键词: 英国 脱欧 药品 医疗器械 监管体制 监管机制 |
| 英文关键词: UK brexit pharmaceuticals medical devices regulatory system regulatory mechanism |
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| 摘要点击次数: 905 |
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| 中文摘要: |
| 目的： 了解脱欧后英国在药品和医疗器械监管的最新进展，为开展双边贸易合作和监管科学研究提供有益参考。方法：查阅英国药品与健康产品管理局网站信息和其发布的药品医疗器械监管指南文件，搜集英国脱欧后药品医疗器械监管体制机制主要改革情况及现状，包括其机构职责、组织架构、法律依据、监管机制等。结果与结论：英国脱欧后，确立了新的中央层面的药品医疗器械监管机构，相应的监管法律法规、监管机制也进行了适应脱欧的调整。然而，研究发现，作为脱欧协议一项重要内容， 《北爱尔兰议定书》的实施，使得北爱尔兰地区的药品医疗器械监管不同于大不列颠，仍适用于欧盟法规。另一方面，一系列药品、医疗器械监管制度的改革体现了英国科学、灵活的监管理念，例如引入欧盟审批程序的认可模式、境外多中心数据互认和协作审批，提高了审评审批效率和质量，值得学习和借鉴。 |
| 英文摘要: |
| Objective: To understand the updates of regulations for pharmaceuticals and medical devices in the UK after Brexit in order to provide useful references for bilateral trade cooperation and scientific research on regulations. Methods: By consulting the website of Medicines and Healthcare Products Regulatory Agency (MHRA) and the related guidance for regulations of pharmaceuticals and medical devices published by the MHRA after Brexit, the major reforms and status quo of regulatory system and mechanism of pharmaceuticals and medical devices in the UK were collected, including institutional responsibilities, organizational structure, legal basis and regulatory mechanism. Result and Conclusion: The UK has established a new central regulatory agency for drugs and medical devices after Brexit, and corresponding regulatory laws and mechanism have also been adjusted to Brexit. However, it is found that the implementation of the Northern Ireland Protocol, as an important part of the Brexit Agreement, makes the regulations for pharmaceuticals and medical devices in Northern Ireland which is different from that in Great Britain still applicable to EU regulations. On the other hand, a series of drug and medical device regulatory reforms in the UK, such as introduction of recognition models of the EU approval procedure, and the mutual recognition and collaborative approval of overseas multi-center data, reflected its scientific and flexible regulatory concept and improved the efficiency and quality of the evaluation and approval, which is worth learning and using for reference. |
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