The European Medicines Agency's Ad hoc Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) has agreed to update its recommendations and implement a centralised approach to support manufacturing risk assessments, following a review of ongoing critical shortages of the chemotherapy drugs ifosfamide and cyclophosphamide. The decisions were taken during a meeting on 12 June 2026, the minutes of which were published by EMA on 24 July 2026.
The meeting, co-chaired by EMA Executive Director Emer Cooke and HMA Chair Karl Broich, heard an update from EMA on the shortages, which remain insufficient and unpredictable with frequent changes to supply forecasts. The root causes, engagement with the marketing authorisation holder Baxter, discussions with alternative suppliers in the EU and third countries, and ongoing talks with the US FDA were covered. Baxter presented its current supply outlook, key challenges in restoring normal supply, and mitigation measures including common-language packaging, redistribution of available stock, and batch-specific exemptions. Baxter confirmed that available stock is being distributed fairly based on historical demand and contractual obligations, and requested support from National Competent Authorities to grant language exemption authorisations for common-language packaging.
In closed discussion, the MSSG agreed to update its recommendations to include specific recommendations to manufacturers, implement a centralised approach to support manufacturing risk assessments, and assure commitment to providing regulatory flexibilities where appropriate. The next MSSG meeting was scheduled for 17 July 2026.
The shortages primarily impact patients requiring these chemotherapy treatments, as well as healthcare providers and hospitals managing cancer care. Baxter, as the main supplier, faces operational and regulatory challenges in restoring supply. National competent authorities are called upon to facilitate regulatory flexibilities, such as language exemptions, to ease distribution. The EMA and MSSG are coordinating efforts to mitigate the crisis, balancing patient safety with the need for rapid access to medicines.