摘要
本文旨在分析新型冠状病毒肺炎(COVID-19)疫情下血液制品在安全性上存在的风险,研究世界卫生组织、美国FDA以及血浆蛋白治疗制剂协会在COVID-19疫情下保证血液制品安全性的应急对策,为我国血液制品监管在突发公共卫生事件时的应对措施提出改进的建议。运用文献资料法、比较研究法和描述性研究法,分析COVID-19疫情下我国血液制品监管在应对突发公共卫生事件时存在的问题。我国在应对突发疫情或传染性公共卫生突发事件时,政府监管部门应当与血液制品生产企业、行业协会、专业咨询团队加强沟通合作,及时提供科学性的行业指南,并充分发挥行业协会作用,保证我国已上市血液制品的安全性。
To analyze the safety risks of blood products during the COVID-19 pandemic,and to study the emergency countermeasures of the World Health Organization(WHO),the US FDA(FDA)and the Plasma Protein Therapeutics Association(PPTA)to ensure the safety of blood products during the COVID-19 pandemic,in order to suggest improvements for blood product regulation in China in response to public health emergencies.This article uses literature review,comparative research and descriptive research methods to analyze the existing problems of blood product regulation in response to public health emergencies during the COVID-19 pandemic.When responding to sudden epidemic situations or infectious public health emergencies,Chinese government regulatory agencies should strengthen communication and cooperation with blood product manufacturers,industry associations,and professional consulting teams,providing timely scientific industry guidelines to give a full play as the role of industry associations so as to ensure the safety of blood products on the market.
作者
田伯凯
张华
TIAN Bo-kai;ZHANG Hua(Department of Industrial Engineering and Management,College of Engineering,Peking University,Beijing 100871,China;Center for Pharmaceutical Information and Engineering Research,Peking University,Beijing 100871,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2021年第19期1794-1800,共7页
Chinese Journal of New Drugs
