The European Medicines Agency (EMA) convened its Medication Shortages Working Party on June 17, 2025, addressing pressing issues related to the availability of essential medicinal products across member states. The meeting, held virtually via Teams, was led by Chair Monica Dias alongside Vice-Chair Magdalena Rychter from Poland.
Assessing the Global Impact on Medicine Supply
A significant portion of the discussion focused on the international factors influencing the supply chain of both human and veterinary medicines. Subgroup feedback highlighted the effectiveness of current crisis monitoring and preparedness strategies. Additionally, updates on antibiotic availability emphasized ongoing preparedness activities amidst fluctuating global conditions.
Addressing Ongoing and Emerging Shortages
The Working Party reviewed several critical shortages, including the discontinuation of insulin-containing products and the scarcity of GLP-1 receptor agonists. Specific cases such as Moventig CAP by Grünenthal and Biltricide NAP by Bayer were examined, alongside the voluntary solidarity mechanism’s outcomes for venlafaxine products. Updates on other shortages, including Ecalta CAP and NovoSeven CAP, were also presented, highlighting the need for continuous monitoring and mitigation efforts.
**Inferences:**
- Global supply chain disruptions significantly impact the availability of essential medicines in Europe.
- Proactive crisis monitoring is crucial for anticipating and managing shortages.
- Collaborative mechanisms like the voluntary solidarity procedure can alleviate specific drug shortages.
Strategic Recommendations and Future Steps
The Executive Steering Group on Shortages and Safety of Medicinal Products provided insights from their recent meeting, proposing recommendations to address vulnerabilities in the supply of anti-D immunoglobulin. Feedback was also sought on the Vulnerability Assessment Methodology and the voluntary solidarity mechanism, aiming to strengthen the overall preparedness framework.
The Global Regulatory Working Group on Drug Shortages convened to discuss second-quarter developments, ensuring that international collaboration remains robust in mitigating shortages. The meeting concluded with actionable steps and scheduled the next session for July 14, emphasizing the continuous commitment of the EMA to safeguard medicine availability.
Ensuring a stable supply of essential medicines requires not only vigilant monitoring but also adaptive strategies to respond to emerging threats. The EMA’s comprehensive approach, involving multiple stakeholders and proactive measures, plays a pivotal role in maintaining public health standards across Europe. Stakeholders are encouraged to engage with the agency’s initiatives and contribute to a resilient pharmaceutical supply chain.
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