News
On 7 June 2022, EMA's Medicines Shortages Steering Group (MSSG) adopted the list of critical medicines for the COVID-19 public health emergency. The medicines included in the list are authorised for COVID-19 and their supply and demand will be closely monitored to identify and manage potential or actual shortages.
Given the current stage of the pandemic, the published list contains all the approved vaccines and therapeutics in the European Union (EU) to prevent or treat COVID-19. It will be updated to reflect changes in the pandemic situation which may give rise to an increased risk of shortages of particular medicines, or following the authorisation of new medicines. The list does not replace national guidance on vaccination and the clinical management of COVID-19.
Marketing authorisation holders (MAHs) of medicines included in the list are required to regularly update EMA with relevant information, including data on potential or actual shortages and available stocks, forecasts of supply and demand. In addition, Member States will provide regular reports on estimated demand for critical medicines at national level. This will enable the MSSG to recommend and coordinate appropriate EU-level actions to the European Commission and EU Member States in order to prevent or mitigate potential or actual shortages of critical medicines to safeguard public health. EMA will liaise individually with the MAHs and national competent authorities to inform them of the timelines, processes and tools to collect the required information following the adoption of the list.
The MSSG was recently established under Regulation (EU) 2022/123, which assigns a reinforced role to the Agency in crisis preparedness and management for medicines and medical devices to monitor shortages and ensure a robust response to major events or public health emergencies, and to coordinate urgent actions on the supply of medicines within the EU. The Regulation formalises and strengthens the governance structures EMA had put in place to ensure swift and coordinated action during the COVID-19 pandemic. One of the MSSG's tasks is to establish lists of critical medicines needed during a public health emergency that require close monitoring because of a possible increased risk of shortages.
The MSSG adopted the list for COVID-19 medicines following consultation with the Medicines Shortages Single Point of Contact Working Party (SPOC WP), the Emergency Task Force (ETF) and EMA's Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP), as established in the recently adopted methodology to create lists of critical medicines. The list has also been shared with EU industry trade associations.
Interested in learning more? Contact us today to find out how we can help not only with your EMA/FDA submissions, but all of your global regulatory needs.