EMA's extended mandate
On 1 March 2022, EMA’s mandate was extended with the entry into force of the regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices.
Throughout 2022, the extension of EMA’s mandate led to the creation of new structures and mechanisms to fulfil this new role.
The Agency became stronger thanks to the European Commission’s decision to extend our mandate. This is a recognition of the Agency’s efforts and successes during the pandemic. The extended mandate formalises some of our existing procedures, but also provides us with new tools to respond effectively to future public health crises, tackle medicine shortages and improve the monitoring of medical devices and their authorisation.
The Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)
With the extended mandate, a new executive body, the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), was established, comprising representatives from EMA, EU Members States, the European Commission and patient and healthcare professional representatives. The group’s role is to respond to medicine supply issues caused by major events or public health emergencies, and to coordinate swift actions within the EU.
Lists of critical medicines
One of the key responsibilities of the MSSG is to establish lists of critical medicines needed during a major event or a public health emergency that require close monitoring of supply and demand, with a view to identifying any actual or potential shortages of those medicinal products. In 2022, EMA published lists of critical medicines for COVID-19 and monkeypox (mpox).
Medicines Shortages Single Point of Contact (SPOC) Working Party
The Medicines Shortages Single Point of Contact (SPOC) Working Party was formally established in May 2022. It is responsible for monitoring and reporting events that could affect the supply of medicines in the EU. The SPOC Working Party provides recommendations to the MSSG on all matters related to the monitoring and management of medicines shortages.
Industry Single Point of Contact network (iSPOC)
The extended mandate also comes with new obligations for companies. Since September 2022, every marketing authorisation holder in the EU has to register an iSPOC to enable rapid communication between EMA and companies to detect, report, and prevent or manage supply and availability issues of medicines included in a list of critical medicines for a ‘public health emergency’ or a ‘major event’.
Companies have to submit their information via IRIS, EMA’s secure online platform for handling product-related scientific and regulatory procedures.
The Emergency Task Force (ETF)
The Emergency Task Force (ETF) was formalised in April 2022, as part of the extended mandate. This is a recognition of the pivotal role the task force played throughout the COVID-19 public health emergency. The ETF provides scientific advice and reviews evidence on medicines that could be used for prevention or treatment during a public health emergency. It also offers scientific guidance to facilitate clinical trials and supports EMA’s scientific committees with the authorisation and safety monitoring of medicines and with recommendations on the use of medicines before authorisation.
The EU Vaccine Monitoring Platform (VMP)
The EU Vaccine Monitoring Platform (VMP) was established in May 2022 as a collaboration between EMA and the European Centre for Disease Prevention and Control (ECDC), with the goal to generate real-word evidence (RWE) through EU-funded post-authorisation studies on vaccine use, safety, and effectiveness. As an important milestone for the European Health Union initiative, the VMP ensures the prioritisation, design, and implementation of studies, and interprets and communicates the results. The Immunisation and Vaccine Monitoring Advisory Board (IVMAB), a multidisciplinary panel with representatives from the European Commission, ECDC’s National Focal Points, EMA’s Emergency Task Force (ETF), and EMA’s committees on human medicines (CHMP) and safety of medicines (PRAC), advises EMA and ECDC on the VMP research agenda.
With the new VMP we have an instrument in place through which we will prioritise research, fund independent studies and complement our knowledge of how vaccines work in real life. The additional evidence generated through these independent studies will enhance our ability to continuously monitor the safety and effectiveness of vaccines. This will improve the robustness of our decision making, which is essential to build and maintain people’s trust in these key products.
Medical devices expert panels
The new mandate transferred the coordination of 12 medical device expert panels from the European Commission to EMA. The objective of the panels is to improve the safety of certain high-risk medical devices marketed in the EU and the European Economic Area (EEA).