Medicine shortages

Medicine shortages arise for a wide range of reasons and are a result of complex global dynamics. Strengthening the reliable availability of medicines remains a priority for the EMRN. EMA contributes to this effort by closely monitoring the situation across the EU, coordinating actions to address critical shortages and maintaining clear communication with all key actors, from manufacturers and national regulators to healthcare professionals and patients.

Monitoring EU shortages

Shortages are monitored by the SPOC Working Party. This group allows representatives from all Member States to regularly report shortages in their countries and exchange information on mitigation measures. In 2025, the SPOC Working Party and its subgroups met 31 times. The group received 70 notifications of critical shortages for discussion and received 18 requests for information. In January 2025, the European Shortages Monitoring Platform, a digital platform that centralises and automates data collection from NCAs and MAHs, became fully operational. This will greatly support the work of the SPOC Working Party.

Preventing and managing critical shortages

The SPOC Working Party can escalate critical shortages or flag events that might lead to shortages to a group composed of heads of NCAs, patient and healthcare professional representatives, the European Commission and EMA. This is the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). The group met eight times in 2025. MAHs were invited to provide an oral explanation on shortages of the medicine Zypadhera as well as to present input on the methodology proposed by EMA to identify vulnerabilities in the supply chains of critical medicines.

The MSSG also coordinates requests for the voluntary solidarity mechanism . This tool allows Member States to support each other in the face of a critical medicine shortage. It enables any Member State facing a critical shortage to request assistance from other Member States in obtaining stocks for a period of time. This mechanism can only be used under limited conditions and was developed as a last resort for Member States after they have exhausted all other possibilities. In 2025, six of these procedures were launched. In all cases, at least one Member State was able to provide support.