The European Medicine’s Agency (EMA) has published the updated Union list of critical medicines for 2026. This list identifies medicines whose continued supply is considered a priority at the EU level. It supports coordinated work to prevent shortages and reduce the risk of serious harm to patients.
EFA provided feedback highlighting that many medicines used daily by patients with allergy, asthma, COPD and atopic eczema remain outside the priority list, despite the urgency raised by patients across Europe.
How is the Union list used?
First introduced in 2023, the Union list is designed to help EU and national authorities work from a shared set of priorities. It enables the EMA, the Heads of Medicines Agencies at national level and the European Commission to take on more proactive, coordinated measures to prevent medicine shortages and manage supply risk.
A critical medicine is identified by combining two criteria:
- Seriousness of the disease
- Availability of alternative medicines
EU Member States assign critical medicine status based on a methodology developed with input from key stakeholder groups, including patient organisations like EFA.
EFA input into the Member State review 2025
In its stakeholder feedback, EFA highlighted medicines and groups that should remain prioritised for supply continuity and keep on the list: Cefazolin, Cefalexin, Linezolid, Fluconzanole, Voriconazole, Monoclonal antibodies and antibody drug conjugates, Budesonide in combination with formoterol, Aminophyliline, R03C Adrenergics - Beta2 agonist, bronchodilator.
What EFA sees as missing?
During the stakeholder feedback step, it was not possible to propose the addition or removal of any other active substance groups beyond the scope of the Member State review. Even so, EFA sees clear gaps for our disease areas, including medicines that help keep chronic conditions stable and reduce exacerbations. Here is the list of missing priorities:
- Antihistamines for systemic use: injectable first-generation antihistamine and oral second-generation and one third-generation antihistamine.
- Treatments for Atopic Eczema such as topicals, more innovative ones, etc. (e.g. mometasone, clobetasone, betamethasone, Baricitinib, and newer ones e.g. tacrolimus topical, tralokinumab, abrocitinib, etc.)
- A range of asthma and COPD treatments: (e.g. beclomethasone-formoterol, budesonide-formoterol, montelukast, omalizumab, tiotropium, etc.)
- RO3Ds medicines are not included in the list. EMA should consider montelukast and omalizumab critical for allergies.
- Only R05C expectorants (excluding combinations with cough suppressants) are included, while other groups and combinations can help prevent deterioration and exacerbations in vulnerable patients.
What changed in the latest update of the Union list?
The network assessed 61 active substance groups and combinations and added 9 of these to the list.
EMA notes that EFA’s feedback on the importance of cefazolin, cefalexin, linezolid, fluconazole intravenous, voriconazole and aminophylline was shared with the Member States. Member States were asked to take the feedback into account and determine whether their original criticality assessment should be modified. Following that process, fluconazole intravenous was added to the Union list. No other changes were made to the Member States’ classification based on EFA’s remaining feedback.
The link to the Critical Medicines Act
The Union list is part of a broader EU approach to shortages, alongside wider legislative work to strengthen Europe’s supply security and manufacturing resilience. The proposed EU Critical Medicines Act is one key element of that package. In January 2026, European Parliament approved its position, opening the way for negotiations with Council of the European Union and the European Commission.
Next update of the list – notify your authorities!
In the first quarter of the year, EFA will work with its community of members to prepare input on the medicines that should be added or removed in the next review of the Union list due in December 2026.
EFA also encourages respiratory patients and patient groups to notify their national authorities of medicines to be prioritised by the EU in the next version of the list.