| 袁利佳,汪小燕,杨志敏,张宁.突破性治疗药物程序在药品注册体系中的作用及展望[J].中国药事,2022,36(9):973-983 |
| 突破性治疗药物程序在药品注册体系中的作用及展望 |
| The Role and Prospection of Breakthrough Therapy Drug Program in Drug Registration System |
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| DOI：10.16153/j.1002-7777.2022.09.002 |
| 中文关键词: 突破性治疗 药品注册 药品审评 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: breakthrough therapy drug registration drug evaluation NMPA FDA EMA |
| 基金项目: |
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| 摘要点击次数: 1170 |
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| 中文摘要: |
| 目的：进一步完善我国突破性治疗药物程序并发挥其在药品注册体系中的作用。方法：通过梳理美国食品药品管理局(FDA)突破性治疗认定(BTD)、欧洲药品管理局(EMA)优先药物计划 (PRIME)和我国国家药品监督管理局(NMPA)突破性治疗药物程序和案例，进一步探索优化我国突破性治疗药物程序在药品注册体系中的发展方向。结果与结论：FDA、EMA和NMPA的药品注册体系中均具有突破性药物治疗程序。FDA自2012年7月实行加快程序中的突破性治疗认定，通过大量案例积累了相对完善的管理经验，EMA的PRIME专人专管的政策支持以及明确的资格申请数据要求，均具有借鉴意义。我国突破性治疗药物法规于2020年落地实施后，至今也积累了一定案例。通过对FDA、EMA和 NMPA关于BTD的法规对比，为我国突破性治疗药物程序实施提供建议。 |
| 英文摘要: |
| Objective: To further promote the breakthrough therapy drug program in China and enhance its role in drug registration system. Methods: By combing the Breakthrough Therapy Designation (BTD) of the US Food and Drug Administration, the Priority Medicines Program of the European Medicines Agency, PRIME and Breakthrough Therapy Drug Procedures and Cases of the National Medical Products Administration (NMPA), to further explore and optimize the development direction of breakthrough therapy program in drug registration system in China. Results and Conclusion: The FDA, EMA and NMPA all have breakthrough drug treatment programs in drug registration system. It has been nearly 9 years since FDA implemented the BTD in the accelerated procedure in July 2012. Through a large number of cases, FDA has accumulated relatively perfect management experience. The policy support of EMA PRIME's special person and clear data requirements for qualification application are of reference significance. Since Breakthrough Therapy Drug Regulations in China were implemented in 2020, some cases have been accumulated so far. The regulations of FDA, EMA and NMPA on BTD are compared to provide suggestions for the implementation of breakthrough therapy drug program in China. |
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