欧盟关键药物清单的第一个版本已达成一致，以帮助避免欧盟潜在的短缺-动脉网

First version of the Union list of critical medicines agreed to help avoid potential shortages in the EU

EMA 等信源发布 2023-12-12 19:10

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The list is an important tool to support the EU’s efforts in ensuring supply security and preventing shortages of critical medicines. Inclusion in the list does not mean that the medicine is likely to experience a shortage in the near future. It means that the prevention of shortages is particularly important as a shortage could cause significant harm to patients and pose important challenges to health systems.

该清单是支持欧盟努力确保供应安全和防止关键药物短缺的重要工具。列入名单并不意味着这种药物在不久的将来可能会出现短缺。这意味着预防短缺尤为重要，因为短缺可能对患者造成重大伤害，并对卫生系统构成重大挑战。

A medicine is considered critical if it is used in serious diseases and cannot be easily replaced by other medicines, for example in case of a shortage. It is included in the Union list of critical medicines if it meets certain criteria, including being critical in more than one third of EU/EEA countries.The list contains active substances covering a wide range of therapeutic areas, and includes vaccines and medicines for rare diseases.

如果一种药物用于严重疾病，并且不容易被其他药物替代，例如在短缺的情况下，则被认为是至关重要的。如果它符合某些标准，包括超过三分之一的欧盟/欧洲经济区国家的关键药物，它就会被列入欧盟重症药物清单。该清单包含涵盖广泛治疗领域的活性物质，包括用于罕见疾病的疫苗和药物。

It reflects the outcome of the review of 600 active substances taken from six national lists of critical medicines . The Union list will be expanded in 2024 and will then be updated every year.The review was carried out with all EU Member States, and criticality was assigned based on an agreed methodology developed in consultation with key stakeholder groups, including patients’ and healthcare professionals’ organisations and industry associations. Medicines on the list can continue to be prescribed and used as usual by patients and healthcare professionals.

它反映了对六种国家危重药品清单中600种活性物质的审查结果。工会名单将于2024年扩大，然后每年更新。审查是与所有欧盟成员国一起进行的，并且根据与关键利益相关者群体（包括患者和医疗保健专业人员组织以及行业协会）协商制定的商定方法来分配关键性。清单上的药物可以继续由患者和医疗保健专业人员照常开具和使用。

Additional reporting requirements for marketing authorisation holders and national competent authorities will be established and become effective once the proposed pharmaceutical legislation becomes applicable.The publication of the Union list will not impact existing or to-be-established national lists of critical medicines.

一旦拟议的药物法规适用，将制定上市许可持有人和国家主管部门的其他报告要求，并生效。联盟名单的公布不会影响现有或即将建立的国家危重药品清单。

However, it will support the network’s efforts in d.

然而，它将支持该网络在d的努力。