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英国脱欧专题:EMA活动优先顺序和交付

2017-08-15 蒲公英

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:

  • the coordination of actions to protect the safety       of patients in all EU Member States;

  • 保护所有EU成员国患者安全的协作活动;

  • inspections across the EU;

  • EU境内检查;

  • maintenance of critical IT applications used by       all Member States.

  • 维护所有成员国使用的关键IT软件。

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:

  • the proactive publication of clinical data;

  • 临床数据主动公开;

  • initiatives to promote the availability of       medicines;

  • 促进药品可获得性活动;

  • contributions to the fight against antimicrobial       resistance;

  • 抗击抗菌耐药性;

  • collaboration with health technology assessment       bodies.

  • 与卫生技术评估单位的协作。

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:

  • the development of a new publicly available online       information source on all medicines marketed in the EU (the European       medicines web portal);

  • 在EU上市的所有药品在线公众信息资源建立(欧洲药品网页商品)

  • work on the e-submission project that will allow       applicants to electronically submit documents linked to authorisation       requests for human and veterinary medicines in a secure and efficient       way;

  • 电子申报项目工作:让申报人可以以安全有效的电子方式提交文件,链接至人药和兽药文件官方要求;

  • the development of a transparency roadmap that       lays out future transparency measures of the Agency;

  • 官方为未来透明度措施所建立的透明度发展规划;

  • participation in the benchmarking of medicines       regulatory authorities in the EU as of 2018.

  • 参与2018年EU的药品法规机构标准制订。

Activities scaled back  include:压缩的活动包括:

  • audits and corporate governance and support       activities;

  • 审计和公司管理及支持活动;

  • participation in and organisation of meetings and       conferences.

  • 参与和组织会议。

 

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