Regulation on EMA’s extended mandate becomes applicable

The regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices becomes applicable as of today, 1 March 2022. It puts some of the structures and processes established by EMA during the COVID-19 pandemic on a more permanent footing, while entrusting several new tasks to the Agency.

EMA is now responsible for monitoring medicine shortages that might lead to a crisis situation, as well as reporting shortages of critical medicines during a crisis. The Agency will also coordinate responses of EU / EEA countries to shortages of critical medical devices and in-vitro diagnostics in crisis situations, after an initial transition period up to 2 February 2023.

Over the next few weeks and months, EMA will set up a number of new bodies and formalise existing ones to manage the new tasks.

In preparation for the application of the new regulation, EMA has set up the permanent secretariat to support 12 medical device expert panels established by the Medical Devices Regulation in order to improve the safety of medical devices marketed in the EU / EEA. The expert panels, previously managed by the Commission’s Joint Research Centre, provide opinions and views to notified bodies on the scientific assessment of clinical and performance evaluations of certain high-risk medical devices and in-vitro diagnostics.

In addition, in order to ensure a robust response to major events in relation to shortages, the legislation establishes an Executive Steering Group on Shortages and Safety of Medicinal Products (also known as the Medicines Shortages Steering Group, MSSG).

The Emergency Task Force (ETF) is expected to start operating under the new rules from mid-April. Its responsibilities include: providing scientific advice on the development of products intended for use during a public health emergency, reviewing scientific data, providing recommendations on the use of unauthorised medicines, and coordinating independent vaccine effectiveness and safety monitoring studies. The composition and Rules of Procedure of the MSSG and ETF will be considered for endorsement by EMA’s Management Board in March.

Other key milestones planned for the coming weeks and months include: updating the role of the EU Single Point of Contact (SPOC) network, a system that EMA and national competent authorities use to exchange information on shortages. Under the new mandate, the SPOC will support the MSSG and provide recommendations on all matters relating to monitoring and management of shortages and availability issues during a crisis, as well as outside crisis situations; providing guidance to companies on the industry SPOC (i-SPOC) network; updating EMA’s plan for Emerging Health Threats; establishing a list of the main therapeutic groups of medicines necessary for emergency care, surgeries and intensive care, to help prepare the lists of critical medicines to respond to public health emergencies or major events.

EMA is organising a workshop on 1 April to inform stakeholders of its extended mandate and explain the plans and timelines for its implementation, and to listen to stakeholders’ views and any concerns. The workshop will be broadcast live on EMA’s website.