摘要
新冠肺炎疫情防控期间,各级药品监管部门积极开展新型冠状病毒检测试剂、医用口罩、隔离衣等多类按医疗器械管理的防疫物资应急审批工作,亟需由国家药品监管部门统一采集、共享、公开全国防疫相关医疗器械产品和企业信息,使相关政府部门和国内外公众能及时获取权威信息。国家药品监督管理局信息中心面对数据分散、数据质量参差不齐、数据及时性和数据内容难以满足防疫需要等困难,理顺和创新工作机制,明确唯一的防疫相关医疗器械信息汇聚共享与公开通道,强化统筹协调提高数据及时性,各方联动不断提高数据质量,一数一源加强数据应用,为我国及时掌握和公开防疫相关医疗器械应急审批信息、守住防疫物资生产和出口质量关、争取国际社会的口碑与支持提供有力保障。同时,也为今后公共安全事件中的信息汇聚共享与公开保障积累了经验。
During the COVID-19 prevention and control,emergency approval of medical devices usd for preventing COVID-19,such as SARS-CoV-2 testing kit,surgical mask,isolation gouns,etc.was carried out by drug regulatory department in China.In order to publish authoritative information on related products and enterprises in a timely manner,there was an urgent need of gathering,sharing and disclosure the information of these medical devices.Center for Information of NMPA(NMPAIC)solved the problems of data dispersion,uneven data quality,data timeliness and content not meet the needs of epidemic prevention,identified the unified channel of gathering,sharing and disclosure information,improved data quality and timeliness,enhanced data application,and summarized the inspiration of information gathering,sharing and disclosure in the future public emergency events.
作者
唐菀晨
陆颖
TANG Wanchen;LU Ying(Center for Information of NMPA, Beijing 100044, China)
出处
《中国医药导刊》
2020年第10期714-717,共4页
Chinese Journal of Medicinal Guide
关键词
新冠肺炎
信息汇聚
信息共享
信息公开
Coronavirus disease 2019(COVID-19)
Information gathering
Information sharing
Information disclosure
