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’.
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 focused 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), and 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.
To continue reading this article please go to EMA .