Executive Steering Group on Shortages and Safety of Medicinal Products
The role of the European Medicines Agency's (EMA) Executive Steering Group on Shortages and Safety of Medicinal Products is to ensure a robust response to medicine supply issues caused by major events or public-health emergencies. It coordinates urgent actions within the European Union (EU) to manage medicine supply issues and issues related to the quality, safety and efficacy of medicines.
EMA established this group in March 2022 in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123). For more information, see Crisis preparedness and management.
The group is also known as the 'Medicine Shortages Steering Group' or MSSG.
The group's responsibilities include:
- establishing lists of the main therapeutic groups of human medicines that are being used in emergency care, surgeries and intensive care;
- establishing lists of critical medicines that need to be monitored for supply issues during a major event or a public-health emergency;
- monitoring the supply and demand of critical medicines to identify any potential or actual shortages of these medicines;
- providing recommendations and coordinating activities that aim to prevent shortages or mitigate their effects;
- advising the European Commission on whether medicine shortages and other ongoing or imminent events should be recognised as 'major events';
- evaluating information on the quality, safety and efficacy of medicines affected by public-health emergencies and other major events, and consider the need for urgent and EU coordinated actions;
- providing recommendations on actions to be taken at EU level relating to medicine shortages and the quality, safety and efficacy of medicines, to the European Commission and to EU Member States.
In carrying out its reponsibilties, the group may consult EMA's scientific Committees, their working parties, and other expert groups, including the Emergency Task Force (ETF).
When a major event or public health emergency may lead to medicine shortages, the group is supported by EMA's Medicine Shortages Single Point of Contact (SPOC) Working Party.
During major events affecting the efficacy, safety or quality of medicines, the work of the group is supported by EMA's scientific committees, their working parties, expert groups or the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) / Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv).
The European Commission or EU Member States can also raise issues of concern to the group for advice on urgent and coordinated EU action.
The members of the Executive Steering Group include:
- representatives of EU Member States;
- one representative of the European Commission;
- one EMA representative.
The group is co-chaired by EMA and by a representative of one EU Member State.
More information on the group's responsibilities, composition, procedures and activities is available in this document:
Below (in alphabetical order of the country they represent) are the current members of the Executive Steering Group on Shortages and Safety of Medicinal Products. The members' declarations of interests are available in the European expert list.
|European Medicines Agency|
|Co-chair (Member States)|
|Affiliation||Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM|
|Affiliation||European Commission. DG SANTE - Health and Food Safety B4|
|Affiliation||Austrian Agency for Health and Food Safety|
|Name||Xavier De Cuyper|
|Affiliation||Federal Agency for Medicines and Healthcare Products (FAMHP)|
|Name||Bogdan Yavorov Kirilov|
|Affiliation||Bulgarian Drug Agency|
|Affiliation||Agency for medicinal products and medical devices of Croatia|
|Affiliation||Ministry of Health - Pharmaceutical Services|
|Affiliation||State Institute for Drug Control|
|Name||Lars Bo Nielsen|
|Affiliation||Danish Medicines Agency|
|Affiliation||State Agency for Medicines|
|Affiliation||Finnish Medicines Agency|
|Affiliation||National Agency for the Safety of Medicine and Health Products|
|Affiliation||Federal Institute for Drugs and Medical Devices|
|Affiliation||National Organization for Medicines|
|Affiliation||National Institute of Pharmacy and Nutrition|
|Affiliation||Health Products Regulatory Authority (HPRA)|
|Name||Domenico Di Giorgio|
|Affiliation||Italian Medicines Agency|
|Affiliation||State Agency of Medicines|
|Affiliation||State Medicines Control Agency|
|Affiliation||Ministry of Health|
|Affiliation||Malta Medicines Authority (MMA)|
Medicines Evaluation Board
|Affiliation||Chief Pharmaceutical Inspectorate|
|Name||Rui Santos Ivo|
|Affiliation||National Authority of Medicines and Health Products|
|Name||Razvan Mihai Prisada|
|Affiliation||National Authority of Medicines and Medical Devices of Romania|
|Affiliation||State Institute for Drug Control|
|Affiliation||Agency for Medicinal Products and Medical Devices of the Republic of Slovenia|
|Name||Maria Jesus Lamas Diaz|
|Affiliation||Spanish Agency for Medicines and Health Products|
|Affiliation||Swedish Medical Products Agency|
New: A Solidarity Mechanism Working Group advises the Executive Steering Group on setting up a voluntary solidarity forum for EU and European Economic Area (EEA) Member States to seek help from one another in obtaining medicines in case of critical shortages in their own country.
The voluntary solidarity forum supports member countries in exceptional circumstances when they cannot restore medicine supply in case of critical shortages through other measures.
It was set up in July 2023.
A European Shortages Management Platform Working Group advises on implementing the European Shortages Management Platform (ESMP) . It is responsible for:
- developing the technical and functional specifications of the ESMP, including a data exchange mechanism with national systems and the data format for electronic submission;
- strengthening cooperation with the European medicines regulatory network.
It was set up in September 2022.