Facilitating the path to accessibility and strengthening the availability of medicines

Strengthening shortages monitoring and rapid response

Throughout 2025, the MSSG oversaw several critical shortages, including GLP-1 RAs, Visudyne and Zypadhera. For GLP-1 RAs, the MSSG implemented regulatory flexibilities to accelerate the assessment of variations aimed at mitigating shortages and supported a drug utilisation study published in December 2025. The study provided insights into patient characteristics, prescribing trends over the past decade and factors driving the increased demand. Supply conditions improved steadily over the year. For Visudyne, a medicine to treat eye conditions such as age-related macular degeneration and pathologic myopia, which has been subject to shortages since 2020 due to reduced manufacturing capacity, the group agreed to continue regulatory support to accelerate variations needed to establish a new EU supply chain in 2026. For Zypadhera, a medicine to treat schizophrenia and in shortage since 2024 due to manufacturing issues, including quality defects, the marketing authorisation holder presented mitigation measures to the MSSG following a request for support from Finland through the voluntary solidarity mechanism. Beyond these product specific cases, as part of its preparedness activities the MSSG monitored the impact of Hurricane Helene on the availability of perfusion solutions and reviewed mitigation proposals.

Ahead of the 2025–2026 winter season, EMA and the SPOC Working Party closely monitored the supply of antibiotics commonly used to treat respiratory infections. EMA proactively engaged with key marketing authorisation holders to assess supply capacity and reached out to regulators in the southern hemisphere to identify trends from their winter seasons. As of late December 2025, no critical shortages were identified in the EU.

A rapid and effective response to shortages depends on timely, high-quality data. To centralise and streamline the reporting of shortages information across the EU, EMA launched the European Shortages Monitoring Platform (ESMP) on 29 January 2025. The platform enables marketing authorisation holders and NCAs to directly report information on supply, demand and availability of medicines during crises and preparedness actions led by the MSSG. Reporting of shortages for centrally authorised medicines is now mandatory via the ESMP, with further functionality expansion planned for 2026.

Reinforcing the supply chain for critical medicines

A major focus of EMA’s long-term work in 2025 was supporting the strengthening and resilience of supply chains for critical medicines. In April, the MSSG issued recommendations to reinforce the supply chain of radiopharmaceuticals, which are increasingly used in cancer diagnosis and treatment. Rising demand and limited European manufacturing capacity have led to periodic shortages. The recommendations emphasised the need to expand domestic capabilities and the consideration of EUlevel solutions to address transport challenges.

In July, the MSSG issued recommendations addressing vulnerabilities in the supply chain of antiD immunoglobulins, the only available treatment to prevent Rhesus immunisation during pregnancy.These medicines rely entirely on plasma donations containing antiD immunoglobulin, yet donornumbers are low and declining. The recommendations highlighted the need for more robust supply plans, reduced unnecessary use through non-invasive screening, investment in research and increased awareness of plasma donation.

The MSSG’s recommendations are guided by the Union list of critical medicines , which identifies medicines essential to the functioning of EU healthcare systems. The list underwent a review in 2025, with an updated version published in December. It now includes nearly 300 active substances.

Communicating about shortages and supporting public understanding

In November 2025, EMA launched its first co-created communication campaign with European healthcare professional and consumer organisations to raise awareness of medicine shortages. The #ItTakesATeam campaign used videos, social media content and personal stories to highlight how different actors collaborate to support patients during shortages.

EMA also held a public webinar explaining the regulatory processes for managing shortages, how to access reliable information and how the public can contribute to prevention and mitigation efforts. Clear communication remains essential not only for public understanding but also for effective shortages management, helping reassure patients and reducing unnecessary pressure on supply chains during crises.

New EU rules for health technology assessment

In January 2025, the new Health Technology Assessment (HTA) Regulation entered into force.

While EMA's role in the context of the Regulation is supportive in nature, the new framework enables enhanced collaboration across regulatory and health technology assessment decision-makers, reinforcing collective efforts to improve access to medicines for all patients across the EU. Throughout the year, EMA engaged closely with the European Commission and EU Member States to support the successful implementation of this landmark legislation.

Information exchange between EMA and HTA

The new HTA Regulation provides a robust legal basis for the exchange of information between EMA and HTA bodies. Since July 2025, EMA has provided relevant information to the HTA Coordination Group (HTACG) from the assessment of marketing authorisation applications, with regular updates shared at key milestones regarding assessment questions and timelines. Sharing of information from the regulatory assessment carried out by EMA with HTA bodies is critical to enable the ambitious timelines set for HTA Joint Clinical Assessments.

EMA is also conducting, together with colleagues from HTA bodies, parallel scientific advice through the parallel Joint Scientific Consultation (JSC) mechanism. This allows developers to obtain feedback from regulators and HTA bodies on their evidence-generation plans, thereby facilitating the quality and robustness of development plans. During 2025, the first three applications for parallel JSC were initiated and are currently at different stages of the process.

The Regulation also creates an EU framework for the assessment of selected high-risk medical devices to help national authorities make more timely and informed decisions on the pricing and reimbursement of such health technologies. In 2025, EMA initiated new activities related to evidence generation and review planning for medical devices in scope of the Regulation and these activities will be further developed in 2026.

Strengthening collaboration

At the interface between regulatory and HTA assessment, EMA maintains close working relationships with the HTACG, for which the European Commission provides the secretariat. A joint EMA/EC workshop on operational experience took place in September 2025, focusing on efficiency and effectiveness at the interface while preserving the respective remits of regulators and HTA bodies. In terms of evidence requirements, EMA, together with HTA bodies, published in April joint perspectives on understanding evidence challenges, managing uncertainties and exploring potential solutions. Through these close collaborative links, EMA continues to support the implementation of the HTA Regulation to deliver tangible value for patients throughout Europe.

EMA is also conducting, together with colleagues from HTA bodies, parallel scientific advice through the parallel Joint Scientific Consultation (JSC) mechanism. This allows developers to obtain feedback from regulators and HTA bodies on their evidence-generation plans, thereby facilitating the quality and robustness of development plans. During 2025, the first three applications for parallel JSC were initiated and are currently at different stages of the process.

The Regulation also creates an EU framework for the assessment of selected high-risk medical devices to help national authorities make more timely and informed decisions on the pricing and reimbursement of such health technologies. In 2025, EMA initiated new activities related to evidence generation and review planning for medical devices in scope of the Regulation and these activities will be further developed in 2026.