| 袁利佳,陈小明,张宁.我国药品附条件批准程序实施情况及相关思考[J].中国药事,2022,36(10):1093-1102 |
| 我国药品附条件批准程序实施情况及相关思考 |
| The Implementation of Conditional Approval Procedures for Drugs in China and Relevant Considerations |
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| DOI：10.16153/j.1002-7777.2022.10.001 |
| 中文关键词: 药品审评 附条件上市 国家药品监督管理局 美国食品药品管理局 欧洲药品管理局 |
| 英文关键词: drug approval conditional marketing authorization NMPA FDA EMA |
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| 摘要点击次数: 1591 |
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| 中文摘要: |
| 目的：对我国药品附条件批准上市相关政策和实施情况进行深入分析和探讨，参考美国与欧盟药品附条件上市政策，对我国附条件批准上市的实施和推进提出建议。方法：通过梳理药品注册管理办法发布后国家药品监督管理局(NMPA)药品附条件批准上市申请审评审批法规政策实施情况，重点围绕当前法规中的准入条件、准入程序、上市后监管要求、撤销情形以及撤销程序进行综述，针对实施过程中发现的问题，借鉴美国食品药品管理局(FDA)药品加速审批(Accelerate Approval)与欧洲药品管理局(EMA)药品附条件批准(Conditional Marketing Authorisation)经验以及对各国附条件政策进行比较分析，探讨我国药品附条件批准上市政策的发展方向。结果与结论：为了加快具有突出价值的临床急需药品上市，缩短新技术临床应用时间，美国与欧盟均设立了相对完备的附条件上市法规政策及程序。我国的附条件批准制度虽然建立时间较短，但有欧美的经验作为参考，结合我国的临床实践和监管需要， 相关法规也在趋于完善。未来，监管部门更多需要考虑的是对程序和技术要求的细化、制度之间的衔接 (如疫苗的紧急使用授权与附条件批准制度)，以及加强上市后监管等方面。 |
| 英文摘要: |
| Objective: To conduct in-depth analysis and discussion on the relevant policies and implementation of conditional approval of drugs in China, and offer suggestions on the implementation and promotion of conditional approval of listing in China with reference to the conditional listing policies of drugs in the United States and the European Union. Methods: By combing the implementation of regulations and policies of the National Medical Products Administration (NMPA) on the review and approval of drug conditional listing application after the release of Measures for the Drug Registration and Management, focusing on the access conditions, access procedures, post-marketing regulatory requirements, revocation situations and revocation procedures in the current regulations, the problems found in the implementation process were addressed, by learning from the US Food and Drug Administration (FDA) Drug Accelerated Approval, the European Medicines Agency (EMA) Conditional Marketing Authorisation experience and conditional policies of various countries, and the development direction of drug conditional approval and listing policies in China was discussed. Results and Conclusion: To speed up the clinical urgent drug approval with outstanding value and shorten the clinical application time of new technologies, Europe and the United States have set up relatively complete conditional approval regulations, policies, and procedures. Although conditional approval system in China has been established for a short time, it has the experience of Europe and the United States as a reference. Combined with clinical practice and regulatory needs in China, relevant laws and regulations were also improving. In the future, the regulatory authorities need to consider the refinement of procedures and technical requirements, the connection between systems (such as the emergency use authorization and conditional approval system of vaccines), and the strengthening of post-market supervision. |
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