文章摘要
2023年美国FDA批准的新药分析
Review of Novel Drugs Approved by FDA in 2023
投稿时间：2024-07-08  修订日期：2024-10-11
DOI：
中文关键词: FDA  新药审批  罕见疾病  加速审批  “first-in-class”新药
英文关键词: FDA  New Drug Approval  Rare Diseases  Expedited Programs  "First-in-Class" New Drugs
基金项目:
作者单位邮编
麻巧宁 国家药品监督管理局高级研修学院 100073
郑杨 国家药品监督管理局高级研修学院 
元延芳 国家药品监督管理局高级研修学院 
王闻雅* 清华大学附属北京清华长庚医院 102218
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中文摘要:
      目的：对2023年美国FDA批准的新药进行分析，并与我国2023年新药审批相关情况进行对比分析，以供业界参考。方法：通过查阅美国FDA CDER发布的《2023年新药审批总结报告》、我国CDE发布的《2023年度药品审评报告》、Drugs@FDA数据库、NMPA发布的药品批件及CDE公开的上市药品信息，结合相关文献，收集并统计分析2023年FDA批准的新药信息，并与我国的相关情况做一一对比分析。结果与结论：2023年，FDA批准了55个新药，涵盖肿瘤、遗传/罕见病、神经系统疾病等多个疾病领域。51%的新药获得了孤儿药认定，36%的新药被认定为“first-in-class”，65%的新药审批至少使用了一种加速审评程序。获批新药的企业涵盖广泛，从大型制药巨头到中小型生物技术公司均有不同数量的新药获批。我国批准新药74个，疾病领域广泛性和多样性与FDA不相上下，但新药创新性及罕见病药物的开发有待提升。38%的新药审批至少纳入了一种加速上市程序。新药审评用时比2022年减少，但一次性通过率降低，反映了监管趋严性。药企需提升申报资料质量，监管部门需完善药品监管法规，加强药品监管人员的培训和教育，提升其专业水平和国际视野。我国药品市场不仅本土企业活跃，也吸引了国际企业的竞争。期待未来更多高质量新药获批，推动药品监管事业进步。
英文摘要:
      Objective: To analyze the new drugs approved by the U.S. FDA in 2023 and compare them with the new drug approvals in China during the same year, providing a reference for the pharmaceutical industry . Methods: By reviewing the "2023 New Drug Approval Summary Report" released by the US FDA, the "2023 Drug Evaluation Report" released by China's CDE, Drugs@FDA database, drug approvals published by the NMPA, and publicly available information on marketed drugs from the CDE, combined with relevant literature, data on new drugs approved by the FDA in 2023 were collected and statistically analyzed, and compared with the situation in China. Results and Conclusion: In 2023, the FDA approved a total of 55 new drugs, including treatments for various medical fields such as oncology, genetic/rare diseases, neurological disorders. 51% of the new drugs received orphan drug designation, 36% of the new drugs were recognized as “first-in-class”, 65% of the new drug approvals utilized at least one expedited program. Furthermore, the companies that have been approved for new drugs cover a wide range, from large pharmaceutical giants to small and medium-sized biotechnology firms, with varying numbers of new drug approvals. China approved 74 new drugs, and the breadth and diversity of disease fields are comparable to those of the FDA. However, the innovation of new drugs and the development of rare disease drugs need to be improved. 38% of the new drug approvals in China included at least one accelerated marketing process. The time required for new drug review has decreased compared to 2022, but the one-time pass rate has also decreased, reflecting the increasing strictness of regulation. Pharmaceutical companies need to improve the quality of their application materials, and regulatory authorities need to improve drug regulation laws, strengthen the training and education of drug regulatory personnel, and enhance their professional level and international perspective. China's pharmaceutical market is not only active with domestic enterprises but also attracts competition from international companies. Looking forward to the approval of more high-quality new drugs in the future and promoting the progress of drug regulation.
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