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EDQM年度报告发布

EDQM年度报告发布 惠世咨询
2021-07-07
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导读:Highlights of 2020 – EDQM annual report now available

The 2020 annual reportof the European Directorate for the Quality of Medicines & HealthCare(EDQM) is now available, providing a comprehensive overview of its activities,achievements and events.

EDQM 2020年度报告已发布,全面概述了其活动,成就和事件。

While the year 2020 will long beremembered for the COVID-19 pandemic almost bringing the world to a standstill,it was also as a time when health authorities, institutions and the privatesector came together on a global scale to pool resources and organise acollective response. The EDQM, operating on the front lines of public healthprotection, continued to play a vital role, proving once again its relevancefor health systems worldwide.

尽管2020年将因新冠肺炎大流行几乎使世界陷入停滞而长期被人们铭记,但当时卫生当局、机构和私营部门也在全球范围内汇聚资源,组织集体应对。在公共卫生保护第一线开展工作的教育质量管理机制继续发挥重要作用,再次证明了其对全球卫生系统的相关性。

With “business as usual” both impossibleand more necessary than ever, the EDQM quickly transitioned to ensuring thecontinuity of its core activities through a series of measures enabling theEuropean Pharmacopoeia (Ph. Eur.) Commission to respect its work programme;safeguarding the supply of reference standards; ensuring the processing ofapplications for new, revised or renewed certificates of suitability (CEPs);and guaranteeing the quality control of medicines, including the OfficialControl Authority Batch Release (OCABR) procedure, through the OfficialMedicines Control Laboratories (OMCL) Network. The EDQM also maintained itsguidance and standard-setting activities in the areas of blood transfusion,organ, cell and tissue transplantation and consumer health. Communicationstructures were set up, indispensable procedures and processes were adapted andwork organisation as a whole was reformed to weather what was to become aprolonged ordeal.

在不可能且比以往任何时候都更有必要继续经营的情况下,EDQM迅速过渡到通过一系列措施确保其核心活动的连续性,使欧洲药典(Ph. Eur.)得以实施。委员会尊重其工作方案;保障参考标准的供应;确保处理有关新的、修订或续期适宜性证明书的申请;通过官方药物控制实验室(OMCL)网络,保证药物质量控制,包括官方药物控制机构批放行(OCABR)程序。EDQM还在输血、器官、细胞和组织移植以及消费者健康领域继续开展指导和制定标准的活动。建立了沟通机制,调整了不可或缺的程序和流程,改革了整个工作组织,以经受住即将到来的漫长考验。

Moreover, the EDQM actively supportedcompetent authorities, manufacturers and developers of medicines (includingvaccines) and health professionals, and contributed to the wider global effortto combat the coronavirus disease by openly sharing knowledge and offering freeaccess to relevant standards, guidance and training.

此外,EDQM积极支持主管部门、药品(包括疫苗)生产商和开发商以及卫生专业人员,通过公开分享知识、免费提供相关标准、指导和培训,为全球抗击冠状病毒疾病做出了更广泛的贡献。

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