Extended mandate: First meeting of Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)

11 May 2022

On 11 May 2022, the EMA Executive Steering Group on Shortages and Safety of Medicinal Products officially met for the first time. The body, also known as Medicines Shortages Steering Group or MSSG, will be responsible for ensuring a robust response to issues impacting the quality, safety, efficacy and supply of medicinal products during major events or public health emergencies.

The MSSG was established under Regulation 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices to monitor shortages and ensure a robust response to major events or public health emergencies, and to coordinate urgent actions within the European Union in relation to the supply of medicinal products. The Regulation formalises and strengthens the governance structure EMA had put in place to ensure swift and coordinated action during the COVID-19 pandemic.

The MSSG will be active mainly during major events or public health emergencies, but it has also a preparatory role. Its main tasks are to:

• establish lists of main therapeutic groups in crisis preparedness and lists of critical medicines needed during a major event or a public health emergency and that require close monitoring because of a possibly increased risk of shortages; today, the group adopted a Methodology for the establishment of lists of “main therapeutic groups” in crisis preparedness and of the lists of “critical medicines” in the context of a major event and/or public health emergency;
• recommend and coordinate measures to prevent or mitigate potential or actual shortages of critical medicines;
• evaluate information on a major event or a public health emergency, or regarding the quality, safety and efficacy of critical medicines;
• recommend appropriate EU-level actions to the European Commission and EU Member States to safeguard public health.

The Medicines Shortages Steering Group is composed of one representative from each EU Member State, a representative from the European Commission and an EMA representative. Civil society is represented in the group with one observer from EMA’s Patients’ and Consumers’ Working Party and one from its Healthcare Professionals’ Working Party. The co-chairs of the MSSG are Emer Cooke, EMA’s Executive Director, and Karl Broich, the Head of the German Federal Institute for Medicines and the current chair of the Heads of Medicines Agencies (HMA).

EMA will publish the meeting minutes in the coming days.