• Critical Care
• BIOTECHNOLOGY
• CLINICAL MEDICINE
• COMMERCE
• DOCUMENTATION

As part of its extended mandate, the European Medicines Agency (EMA) will be tasked with the monitoring of events, including medicine shortages, which might lead to a crisis situation, as well as with the reporting of shortages of critical medicines during a crisis. Also, coordination of responses and shortage reporting for critical medical devices and in vitro diagnostics occurring in crisis situations will be covered, after an initial transition period.

This new regulation became applicable as of 1 March 2022, except for the provisions on shortages of critical medical devices which will apply as of 2 February 2023. It turns structures and processes established by EMA during the COVID-19 pandemic into a permanent feature and adds several new tasks to the Agency’s area of work. By early 2025, a European Shortages Monitoring Platform will be set up and maintained by EMA to facilitate data collection and reporting by companies and Member States on shortages, supply and demand of critical medicines.

EMA has also been given the responsibility to coordinate EU expert panels to provide advice to Member States and the European Commission on high-risk medical devices and in-vitro diagnostic medical devices. Due to the reinforced mandate, EMA will be able to facilitate a coordinated EU-level response to health crises by:

• monitoring and mitigating the risk of shortages of critical medicines and medical devices;

• provide scientific advice on medicines that may have the potential to treat, prevent or diagnose the diseases causing those crises;

• coordinate studies to monitor the effectiveness and safety of medicinal products intended to treat, prevent or diagnose diseases related to the public health crisis;

• coordinate clinical trials …