| 美国FDA有关药品紧急授权的做法与启示 |
| 投稿时间：2023-09-19 修订日期：2024-05-06 点此下载全文 |
| 引用本文：韩丹,高文,王璐暖,孙蕊,郭明明,舒丽芯.美国FDA有关药品紧急授权的做法与启示[J].药学实践杂志,2024,42(12):533~536 |
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| 基金项目:军队生物安全专项（A3703022001） |
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| 中文摘要:目的 本文旨在通过深入分析美国食品药品监督管理局（FDA）在药品紧急使用授权方面的实践，为我国药品特别审批制度的完善提供有益参考。方法 回顾性分析了美国FDA在2020年1月至2023年6月期间新型冠状病毒感染肺炎（COVID-19）治疗药物的紧急使用授权决策过程。结果 在COVID-19流行期间，FDA共批准了15个COVID-19治疗药物和4个COVID-19疫苗的紧急使用授权，包括上市药品扩大适应证、试验药物紧急使用授权、紧急使用授权后撤销、紧急使用授权后上市等情形。FDA采取了一系列加快药物审批的措施，包括利用已有的临床试验数据、省略动物药效实验、合并临床试验阶段、采用替代性终点指标等。结论 FDA在药品紧急使用授权方面的一些做法，特别是将监管科学方法引入紧急使用授权中，并对紧急使用授权的药品制定主动监测机制等，值得我国借鉴。建议参考FDA在药品紧急使用授权制度方面的经验，进一步优化和完善我国的药品特别审批制度。 |
| 中文关键词:美国食品药品监督管理局 COVID-19 紧急使用授权 药品特别审批 |
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| The approaches and implications of emergency drug authorization by the U.S. FDA |
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| Abstract:Objective To provide valuable insights for improving China’s special drug approval system by conducting an in-depth analysis of the practices of the U.S. Food and Drug Administration （FDA） in granting Emergency Use Authorizations （EUAs） for drugs. Methods A retrospective analysis was conducted on the FDA’s EUA decision-making process for COVID-19 therapeutics between January 2020 and June 2023. Results During the COVID-19 pandemic, the FDA adopted a series of regulatory science approaches to facilitate rapid approval of COVID-19 therapeutic drugs. The FDA granted EUA for a total of 15 COVID-19 therapeutic drugs and 4 COVID-19 vaccines, including expanded indications for marketed drugs, EUA for investigational drugs, revocation of EUA, and marketing after EUA. The main mechods for the rapid approval of EUA drugs by the FDA included the use of existing clinical trial data, omission of animal efficacy testing, merging of phase 1 and phase 2 clinical trials, and the use of clinical outcomes as surrogate endpoints, among other regulatory science methods. Conclusion The practices of the FDA in Emergency Use Authorization (EUA) of drugs, particularly its incorporation of regulatory scientific methods into the EUA process and the establishment of proactive monitoring mechanisms for drugs granted EUA, are worthy of emulation by China. It is suggested that China consider the experience of the FDA in the EUA system for drugs to further optimize and improve its special approval system for drugs. |
| keywords:FDA COVID-19 emergency use authorization drug special approval |
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