Prospect of compassionate use in China from remdesivir

Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2021 Aug 28;46(8):909-914. doi: 10.11817/j.issn.1672-7347.2021.200255.
[Article in English, Chinese]

Abstract
in English, Chinese

Compassionate use may play an important role in responding to major public health emergencies. The Jinyintan Hospital in Wuhan launched the III phase of clinical trials of antiviral drug-remdesivir on February 6, 2020. As an unapproved drug, remdesivir raised great concerns about compassionate use in China. Compassionate use is therapeutic use of unauthorized drugs outside of clinical trials. It is used for critically ill patients with life-threatening diseases and no effective treatment means in China. Patients voluntarily apply to their medical institutions. The Center for Drug Evaluation, National Medical Products Administration shall conduct scientific and reasonable review, approval, and supervision on patients' application for compassionate medication. By analyzing and comparing the current situation of compassionate use at home and abroad, it is expected to provide thinking for the development of compassionate use system in China.

对于紧急重大的公共卫生事件，同情用药或可发挥重要作用。2020年2月6日在武汉金银潭医院启动的抗病毒药物瑞德西韦III期临床试验使得同情用药制度在中国备受瞩目。同情用药是允许医疗需求尚未满足的患者使用未批准上市的药物。中国同情用药适用于患有危及生命、无有效治疗手段的危重患者，先由患者自愿向所在医疗机构提出申请，再由国家药品监督管理局药品审评中心对患者同情用药的申请作出科学、合理的审查、许可及监督。分析对比国内外同情用药现状，可以为中国同情用药制度的发展提供思路。.

Keywords: compassionate use; coronavirus disease 2019; extended use; remdesivir.

MeSH terms

  • Adenosine Monophosphate / analogs & derivatives
  • Alanine / analogs & derivatives
  • Antiviral Agents / therapeutic use
  • Clinical Trials, Phase III as Topic
  • Compassionate Use Trials*
  • Humans

Substances

  • Antiviral Agents
  • remdesivir
  • Adenosine Monophosphate
  • Alanine