The European Shortages Monitoring Platform (ESMP) has officially launched, providing a centralized system for tracking medicine supply and demand across Europe. Developed under Regulation (EU) 2022/123, the platform strengthens the European Medicines Agency’s (EMA) capacity to monitor and respond to medicine shortages, particularly during crises.
The ESMP serves as a real-time reporting tool for both centrally and nationally authorized medicines. Pharmaceutical companies and national medicine authorities are now required to report supply disruptions and demand fluctuations through the platform, ensuring timely interventions to prevent critical shortages.
Improving Transparency in Medicine Availability
For years, European countries have faced increasing challenges in maintaining stable medicine supplies. Disruptions in the supply chain, geopolitical tensions, and unforeseen public health crises—such as the COVID-19 pandemic—have underscored the urgent need for a more efficient and coordinated response system.
The ESMP addresses these issues by consolidating supply and demand data in a single platform accessible to European regulators. The system facilitates quicker response times and enhances cross-border coordination in managing medicine shortages.
Mandatory Reporting and Compliance
As of February 2, 2025, all marketing authorization holders must comply with ESMP reporting requirements for centrally authorized medicines. However, national reporting obligations remain in effect, meaning that companies must also report shortages at the country level. In the Netherlands, for example, pharmaceutical firms are still required to notify the Meldpunt Geneesmiddeltekorten en -defecten (Reporting Point for Medicine Shortages and Defects).
To ensure compliance, companies must register their Industry Single Point of Contact (i-SPOC) with EMA. The i-SPOC network is designed to streamline communication between regulatory bodies and pharmaceutical companies, ensuring that supply issues are identified and addressed as efficiently as possible. Despite this requirement, many companies have yet to complete their registration, raising concerns about the platform’s effectiveness in the early implementation phase.
A New Era in Medicine Supply Monitoring
The launch of the ESMP marks a significant step forward in enhancing medicine availability and reducing the risk of shortages. The platform’s real-time data collection capabilities enable regulatory bodies to anticipate potential shortages, allocate resources more effectively, and implement targeted policy interventions.
At the same time, industry stakeholders stress that greater flexibility is needed in medicine evaluation and reimbursement systems. The Association of Innovative Medicines (VIG) has argued for a more adaptive approach, particularly as personalized medicine and advanced therapies become more common. With the rise of gene and cell therapies, traditional supply chain models may need to evolve to accommodate the increasing complexity of modern pharmaceuticals.
Looking Ahead: Implementation and Future Challenges
While the ESMP is now live, its success depends on widespread adoption and accurate reporting. The effectiveness of the platform will be tested in the coming months, as EMA and national authorities assess whether the system improves responsiveness to supply disruptions.
Future developments may include expanded AI-driven predictive analytics to further enhance medicine supply forecasting. However, the current priority is ensuring full compliance among pharmaceutical companies and national authorities, as incomplete reporting could undermine the platform’s effectiveness.
