Added on 14 April 2025:
'EU actions on radiopharmaceutical supply chain issues' section
EMA has two bodies to carry out its crisis preparedness and management responsibilities:
For more information, see:
EMA and the Heads of Medicines Agencies (HMA) have issued a set of recommendations to address vulnerabilities in the supply chain of radiopharmaceuticals.
Radiopharmaceuticals are substances that contain radioactive compounds. They play a key role in medical diagnosis and treatment, such as cancer treatment.
EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) tailored these recommendations for stakeholders such as the European Commission, EU Members States and pharmaceutical industry. They include:
Regulatory measures alone are insufficient to strengthen the supply chain of radiopharmaceuticals. Other long-term industrial policy measures are also required.
The increasing use of radiopharmaceuticals and Europe's limited manufacturing capacity have led to occasional shortages in EU Member States.
The main vulnerabilities in the supply chain are:
EMA and HMA issued their recommendations to strengthen the supply of radiopharmaceuticals in April 2025.
They are available below:
EMA and the Heads of Medicines Agencies (HMA) are taking action to tackle shortages of glucagon-like peptide-1 (GLP-1) receptor agonists in the EU.
This includes providing recommendations that different stakeholders can take and coordinating EU actions via the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and the Medicine Shortages Single Point of Contact (SPOC) Working Party.
These medicines include:
A surge in demand for some of these medicines since 2022, along with manufacturing capacity constraints, is causing shortages across the EU.
GLP-1 receptor agonists are authorised for the treatment of diabetes or for weight management under certain conditions, or both.
The MSSG has developed recommendations for actions that EU Member States and marketing authorisation holders can take to help tackle GLP-1 receptor agonist shortages.
In addition, the MSSG also urges healthcare professionals and the public to follow key recommendations.
To view the specific recommendations for each stakeholder group, please select the corresponding stakeholder type from the expandable panels below.
Prescribe these medicines in line with their authorised use(s) only, taking guidance from national authorities or applicable national therapeutic guidelines
The list below provides an overview of authorised uses:
Any other use represents off-label use which will worsen existing shortages.
A multistakeholder workshop in July 2024 explored additional measures to improve the supply of these medicine in the European Union / European Economic Area. More information on the workshop is available on the event page:
EMA and the European medicines regulatory network have been closely monitoring the shortages since 2022. They hold regular meetings with the marketing authorisation holders to gain a full oversight of the market, including current and anticipated shortages, and closely monitor the effects of any mitigation actions. EMA also exchanges information with its international counterparts for a global overview.
To ensure that patients receive the medicines they need, EU Member States have facilitated stock redistribution. Some Member States have also implemented tailored measures to control the supply of these medicines within their national healthcare systems.
To get a comprehensive overview of how GLP-1 receptor agonists are used in real life, the MSSG is carrying out a real-world data study via EMA's DARWIN EU.
EMA, the Medicine Shortages Single Point of Contact Working Party (SPOC WP) and the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) collaborate with key stakeholders in the supply chain to prevent and mitigate shortages of antibiotics across the EU.
This collaboration aims to prevent shortages such as those seen in the winter 2022-23. A surge in respiratory infections, coupled with manufacturing delays and production issues, led to shortages of critical antibiotics during that winter.
The focus areas include:
For more information on the current situation in the EU, see: Amoxicillin and amoxicillin/clavulanic acid - supply shortage
Following a surge in respiratory infections across the EU in the winter 2022-23, EMA and the European Commission’s Health Emergency Preparedness and Response Authority (HERA) collected data to estimate the supply and demand in the EU for the following antibiotics used to treat respiratory infections:
Key marketing authorisation holders provided EMA and HERA with data on supply forecasts and production capacity. EMA and HERA matched these data with demand estimates for the winter season in the EU and the European Economic Area.
In July 2023, EMA, the Heads of Medicines Agencies (HMA) and the European Commission issued recommendations through MSSG. These were aimed at ensuring the availability of antibiotics in the autumn and winter of 2023-24.
The recommendations focused on three main preventive actions:
These actions had an impact on the antibiotic shortages situation in the winter 2023-24 with most EU Member States reporting a substantial improvement or resolution of shortages in January 2024.
For more information, see:
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: