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EMA News·· 28 天前AI 评分34

欧盟新建供应链以终结 Visudyne 短缺

New EU supply chain to end Visudyne shortage

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欧盟将通过新建供应链解决 Visudyne 短缺问题,短缺完全解决后 EMA 短缺目录将更新。EMA 正扩展欧洲短缺监测平台(ESMP)功能,以加快行业与监管机构之间关于潜在药品短缺的数据交换。MSSG 在实施欧盟修订药品立法及《关键药品法案》(CMA)关键措施中发挥重要作用,包括对关键药品开展脆弱性评估。

正文

Medicine shortages can have serious consequences for patients and public health and place a heavy burden on healthcare systems. The limited availability of Visudyne has impacted the planning, prioritisation and prescribing of patient treatment. Once the shortage is fully resolved, EMA’s shortage catalogue will be updated.

The MSSG plays a significant role in implementing key measures of the EU’s revised pharmaceutical legislation and Critical Medicines Act (CMA) — supporting a more proactive and coordinated approach to preventing and mitigating medicine shortages. This work includes carrying out vulnerability assessments of critical medicines to identify and address weaknesses in supply chains, such as overreliance on single manufacturing sites and other factors that may increase the risk of shortages.

EMA is also expanding the functionalities of the European Shortages Monitoring Platform (ESMP), a digital tool designed to enable faster, more consistent and more data-driven exchanges on potential medicines shortages between industry and regulators. The enhanced platform will strengthen the EU’s ability to monitor supply issues and take timely measures to improve availability of medicines. 

来源:EMA News · ema.europa.eu