The EUL pathway involves a rigorous assessment of phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy and manufacturing quality.
These data are reviewed by independent experts who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and the plans for further studies.
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来自各国主管部门的专家应邀参加紧急使用审查,参与协助推动必要的国家一级授权使用的决策进程。
Experts from individual national authorities are invited to participate in the EUL review and are engaged to help facilitate the necessary country-level decision process for authorization of use.
Once a vaccine has been listed for WHO emergency use, WHO engages its regional regulatory networks and partners to sensitize national health authorities on the vaccine and its anticipated benefits based on data from clinical studies to date.
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除决定是否使用疫苗之外,每个国家都需要完成准备工作,以便实施紧急使用疫苗相关工作。
In addition to deciding whether to use the vaccine, each country needs to complete a readiness process for the implementation of the vaccine under the EUL.
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生产疫苗的公司也要承诺继续生成数据,使疫苗获得全面批准并通过世卫组织预认证。
The company producing the vaccine also commits to continue to generate data to enable full licensure and WHO prequalification of the vaccine.
WHO prequalification will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine continues to meet the necessary standards of quality, safety and efficacy for broader availability (i.e.
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世界精神卫生日:尊严与精神卫生
World Mental Health Day – 10 October: Dignity in mental health
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2015年10月16日 | 媒体说明
16 October 2015 | Note for Media
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2015年10月9日 ¦ 日内瓦 – 世界各地成千上万精神疾病患者被剥夺了其人权。
9 OCTOBER 2015 ¦ GENEVA – Thousands of people with mental health conditions around the world are deprived of their human rights.