英国脱欧专题:EMA活动优先顺序和交付
翻译:JULIA来源: Julia法规翻译
Prioritisation and delivery ofEMA activities
EMA活动优先顺序和交付(new)
EMA has developed a businesscontinuity plan prioritising the Agency’s activities in order ensure thatthe assessment of medicines is not disrupted and that patients in Europecontinue to have access to high quality, safe and effective medicines in thecoming months and after the UK’s withdrawal from the EU.
EMA已拟定了业务持续规划,对EMA的活动进行优先排序以确保药物评估不会中断,欧洲的患者可以在未来数月和英国退出欧盟之后持续获得高质量安全有效的药品。
In June 2017, EMA's ManagementBoard endorsed the plan that makes available the necessary resources to preparefor Brexit and the move of the Agency and to cope with a potentially significantstaff loss.
2017年6月,EMA管理委员会采纳了该规划,配置了所需资源用以准备英国脱欧,以及总部搬迁,应对潜在员工严重流失。
The plan establishes threepriority levels for EMA's activities according to their impact on publichealth and the ability of the Agency to function properly.
规划中将EMA的活动依据其对公众健康的影响程度,以及EMA正常履行其职能的能力分为三个优先级别。
The Agency will maintain thedelivery of its highest and medium priority activities but has decided to scaleback or temporarily suspend some of its lowest priority activities. Asignificant loss of staff as a consequence of the Agency’s relocation may leadto more restrictions than currently foreseen in the plan.
EMA会维护其最高优先级活动和中等优先级活动的正常交付,但决定压缩或临时搁置一些低优先级别的活动。员工的严重流失使得EMA的搬迁可能会导致其比当前规划中所预见的情况受到更多限制。
EMA will provide updates onthe implementation of its business continuity plan as necessary.
EMA将在必要时对其业务持续规划实施情况进行更新。
Highest priority activities 高优先级活动 | |
Types of activities 活动类型 | Activities either directly related to the assessment and safety monitoring of medicines or vital to maintaining the infrastructure of the European medicines regulatory network, including for example: 直接影响药品评估和安全监测的活动,以及对于维护欧洲药品法规框架基础设施至关重要的活动,包括例如:
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Current status 目前状态 | business as usual 与往常相同 |
Medium priority activities 中等优先活动 | |
Types of activities 活动类型 | Strategic activities, such as: 策略性活动,如:
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Current status 当前状态 | business as usual 与往常相同 |
Lowest priority activities 低优先级活动 | |
Types of activities 活动类型 | Governance and support activities 管理和支持性活动 |
Current status 当前状态 | Activities temporarily suspended include: 临时搁置的活动:
Activities scaled back include:压缩的活动包括:
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