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突发公共卫生事件中的药物使用法规依据 被引量:2

Regulatory basis for drug use during public health emergencies
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摘要 药物是防病治病的武器,在疫情等突发公共卫生事件中具有极其重要的作用。对于新型冠状病毒这类疫情,在疫情爆发时会存在暂无已上市特效药、具有治疗前景的药物仍处于早期研发阶段的情况。在这种突发公共卫生事件中药物的使用既要切实维护公众利益,又要为患者提供使用新型治疗手段的机会。本文对我国突发公共卫生事件药物使用的相关法规进行梳理,以期为疫情阻击战中的新型药物使用提供参考。 Effective drugs are weapons for preventing and curing diseases and play an extremely important role in public health emergencies.For epidemic such as coronavirus disease 2019(COVID-19),there may be no effective drugs on the market at the time of the outbreak,and drugs with promising prospects are still in the early development stage.The use of drugs in such public health emergencies must effectively protect the public interest and provide patients with opportunities to use new treatments.This article reviews the relevant laws and regulations on the drug use in public health emergencies in China so as to provide a reference for the use of new drugs in the epidemic battle.
作者 陈一飞 张景辰 徐瑛 李刚 CHEN Yifei;ZHANG Jingchen;XU Ying;LI Gang(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China)
出处 《上海医药》 CAS 2020年第3期3-7,23,共6页 Shanghai Medical & Pharmaceutical Journal
关键词 突发公共卫生事件 新型冠状病毒 药物 疫情 法规 public health emergencies coronavirus disease 2019(COVID-19) drugs epidemic regulations
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  • 1FDA.Building a stronger defense against bioterrorism. http://www.fda.gov/For Consumers/ConsumerUpdates/ucm048251.htm . 2009
  • 2FDA.Federal Register:Authorization of emergency use of anthrax vaccine adsorbed for prevention of inhalation anthrax by individuals at heightened risk of exposure due to attack with anthrax;extension;availability. http://www.fda.gov/ohrms/dockets/98fr/05-15233.htm . 2009
  • 3FDA.FDA authorizes emergency use of influenza medicines,diagnostic test in response to swine flu outbreak in humans. http://www.fda.gov/bbs/topics/news/2009/new02002.html . 2009
  • 4FDA.TamifluFact sheet for health care providers. www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM143874.pdf . [09-04-27]
  • 5FDA.RelenzaFact sheet for health care providers. http://www.fda.gov/cder/drug/antivirals/influenza/default.htm . [09-04-27]
  • 6FDA.TamifluFact sheet for patients and parents. http://www.fda.gov/down loads/drugs/drugsafety/informationbydrugclass/ucm143876.pdf . [09-04-27]
  • 7FDA.Zanamivir summary fact sheet for patients and parents. http://www.fda.gov/DrugSafety/InformationbyDrugClass/UCM143860.pdf . [09-04-27]
  • 8FDA.Emergency use authorizations questions and answers. http://www.fda.gov/news events/publichealthfocus/ucm153297.htm . [09-04-27]
  • 9FDA.FDA’s emergency use authorization of medical pro-ducts guidance. http://www.fda.gov/oc/guidance/emergencyuse.html . 2009
  • 10FDA.Tamiflu letter for emergency use authorization. http://www.fda.gov/cder/drug/antivirals/influenza/default.htm . 2009

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