EMA has two bodies to carry out its crisis preparedness and management responsibilities:
For more information, see:
EMA, HMA and the European Commission are taking important steps to avoid shortages of antibiotic medicines for European patients, via the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).
This followed a surge in respiratory infections across the EU in winter 2022-23, which led to an increased demand for antibiotics such as amoxicillin (alone and in combination with clavulanic acid), especially for use in children.
The MSSG issued recommendations in July 2023 to help ensure the availability of key antibiotics used to treat respiratory infections during autumn and winter 2023-24.
The group uses data collected by EMA and the European Commission’s Health Emergency Preparedness and Response Authority (HERA) to estimate supply and demand in the EU of these antibiotics:
The data suggest that the supply to the EU of oral formulations of key first and second-line antibiotics for respiratory infections will match demand, assuming that demand does not exceed the average over the last several years.
EMA and DG HERA, in cooperation with the EU Member States, continue to monitor supply and demand closely, and to take action where necessary. This includes regular interactions with marketing authorisation holders to:
For more information, see:
The EU (Union) list of critical medicines enables EMA, the European Commission and the Heads of Medicines Agencies (EMA) to work together to ensure they can take proactive measures to avoid medicine shortages.
It contains human medicines whose continued supply is considered a priority in the EU, to avoid serious harm to patients and help healthcare systems function.
Medicines on this list will be prioritised for EU-wide actions to strengthen their supply chains and minimise the risk of supply disruptions.
The European medicines regulatory network published the first version of the list in December 2023.
It includes both innovative medicines and generic medicines for human use covering a wide range of therapeutic areas - such as vaccines and medicines for rare diseases.
It contains over 200 active substances selected after EU Member States reviewed 600 active substances from existing national lists of critical medicines. The review will continue in 2024 and cover authorised medicines not included in the first review.
A questions and answers document on the Union list is also available.
EU Member States assign critical medicine status based on a methodology developed with input from key stakeholder groups, with patient and healthcare professionals organisations, and pharmaceutical industry associations among them.
A critical medicine is identified by combining two criteria, the seriousness of the disease and the availability of alternative medicines. A medicine also has to meet additional criteria to be included in the list, such as being critical in at least one-third of EU / European Economic Area countries.
The European medicines regulatory network will closely monitor the medicines on the Union list and implement measures to minimise the risk of supply disruptions. It will do so via existing processes and structures, as defined in the mandate of EMA’s Medicines Shortages Single Point of Contact (SPOC) Working Party and its Executive Steering Group on Shortages and Safety of Medicinal Products.
Additional obligations for marketing authorisation holders and national competent authorities are further defined in the upcoming proposed EU pharmaceutical legislation.
As proposed in its October 2023 communication on addressing critical shortages of medicines, the European Commission will also analyse the supply chain of critical medicines to determine potential vulnerabilities.
In such cases, the Commission and EMA's Executive Steering Group on Shortages and Safety of Medicinal Products may propose measures to address vulnerabilities and strengthen security of supply for these medicines, including:
These measures will support the prevention and mitigation of shortages, and ensure appropriate and continued supply of critical medicines for patients and healthcare systems across the EU.
The table below centralises medicine lists that are currently available or being drawn up as well as lists that can be established when a specific need arises, as was the case during the COVID-19 public health emergency:
| Name | Purpose | Mandate | Legal basis |
|---|---|---|---|
Union list of critical medicines | Prevention
| EMA / Heads of Medicines Agencies (HMA) | Proposal for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use |
List of main therapeutic groups of medicines
| Crisis preparedness
| Executive Steering Group on Shortages and Safety of Medicinal Products | Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123) |
| List of critical medicines for a major event | Crisis response
| Steering group on shortages and safety of medicines | Regulation (EU) 2022/123 |
| List of critical medicines for a public health emergency | Crisis response
| Steering group on shortages and safety of medicines | Regulation (EU) 2022/123 |
For more information, see:
A list of main therapeutic groups agreed by the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meetings enables EMA to identify the critical medicines needed in case of a specific public health emergency or major event.
It includes medicines for use in emergency care, surgery and intensive care.
EMA reviews the main therapeutic groups' list every year and whenever necessary to consider relevant developments, such as changes in clinical practice.
In line with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123), the MSSG will draw up a list of critical medicines for each specific public health emergency or major event, and closely monitor the supply and demand of those medicines to prevent or mitigate potential shortages.
EMA can coordinate swift actions across EU Member States to ensure the continued supply of medicines in case shortages happen.
Although marketing authorisation holders have legal reporting obligations for critical medicines under Regulation (EU) 2022/123, they do not have such obligations for medicines on the main therapeutic groups list.
The MSSG consulted widely to draw up the main therapeutic groups list, including with the Medicines Shortages Single Point of Contact (SPOC) Working Party, Patients' and Consumers' Working Party (PCWP), Healthcare Professionals' Working Party (HCPWP), learned societies and industry associations. For more information, see:
For more information, see: