On 7 July 2022, EMA’s Medicines Shortages Steering Group (MSSG) adopted the list of the main therapeutic groups of medicines used in emergency care, surgery, and intensive care. The list forms the basis from which EMA will draw up concrete lists of critical medicines needed to deal with a specific ‘public health emergency’ or a ‘major event’[1]. The medicines on such concrete lists are closely monitored because of a possible increased risk of shortages. If required, EMA can coordinate swift actions across Member States to ensure continued supply.
EMA recently published the first list of critical medicines, focussed on COVID-19 medicines.
This is a new responsibility that comes with the reinforced role of 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.
The MSSG adopted the list of the main therapeutic groups following consultation with the Medicines Shortages Single Point of Contact Working Party (SPOC WP), the Patients’ and Consumers’ Working Party (PCWP), the Healthcare Professionals’ Working Party (HCPWP), learned societies and industry associations. It will be reviewed on a yearly basis and whenever necessary to take into account, amongst others, changes in clinical practice.
While the list of main therapeutic groups is purely informative, the lists of critical medicines impose obligations on companies to regularly update EMA with relevant information, including data on potential or actual shortages and available stocks, forecasts of supply and demand through their Industry Single Point of Contact (i-SPOC). The i-SPOC system is designed to facilitate communication between EMA and marketing authorisation holders of medicines included in a list of critical medicines to detect, report and prevent or manage the supply and availability of these medicines.
EMA launched the registration process of i-SPOCs via its IRIS platform on 28 June. All marketing authorisation holders (MAHs) in the EU must register their i-SPOC by 2 September 2022. EMA has updated the IRIS user guide and published a video demo to support companies with the registration process. The Agency will use its IRIS platform to collect this information and facilitate two-way communication between EMA and MAHs to detect, report, and prevent or manage supply and availability issues for critical medicines.
Regulatory flexibilities to deal with COVID-19 remain in place but their use is decreasing
The MSSG also supported maintaining the exceptional regulatory measures put in place by EMA, the Heads of Medicines Agency and the European Commission in 2020, to facilitate the expedited authorisation of medicines for COVID-19, ensure sufficient medicine supplies and help to deal with travel and other disruptions that could impact on certain regulatory steps. These measures have proven to be adequate and effective, but their use is reviewed regularly considering the epidemiological situation, the authorised medicines for the prevention or treatment of COVID-19, the current status of product availability and shortages and any restrictions. Consequently, the application of these flexibilities has become more exceptional, but they remain crucial to enable timely availability of medicines in certain cases and their use may have to be expanded again should the situation deteriorate. Therefore, it is still possible to apply these exceptional measures during the current pandemic and regulators will consider individual applications on a case-by-case basis.
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