EMA Resolves Visudyne Shortage After Registering New EU Manufacturing Sites for Verteporfin

A single-site dependency on a US-based active substance manufacturer drove the EU's Visudyne (verteporfin) shortage into a controlled distribution regime, and the regulatory pathway used to exit that regime now offers plant heads and QA directors a concrete template for supply chain vulnerability planning. The European Medicines Agency (EMA) confirmed on 4 September 2026 that new manufacturing sites have been registered and supply arrangements finalised, with full restoration of EU supply levels targeted for 2027.

The shortage triggered formal intervention by two governance bodies: the Medicine Shortages Single Point of Contact (SPOC) Working Party and the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). Together, they administered a controlled distribution system to allocate limited Visudyne stock equitably across Member States, a measure that directly affected treatment planning and prescribing prioritisation for patients with wet age-related macular degeneration and choroidal neovascularisation caused by pathologic myopia. Regulatory flexibilities were extended by the rapporteur team and EMA staff to accelerate site registration.

For regulatory affairs leads, the Visudyne case operationalises the EU's revised pharmaceutical legislation and the Critical Medicines Act (CMA) in a way that draft guidance alone cannot. The MSSG's mandate now explicitly includes vulnerability assessments of critical medicines, targeting overreliance on single manufacturing sites as a primary risk factor. Supply chain teams that have not yet mapped single-source dependencies against the Union list of critical medicines should treat this resolution as a prompt to do so.

EMA is simultaneously expanding the European Shortages Monitoring Platform (ESMP) to enable faster, data-driven exchanges between industry and regulators on emerging supply risks. The enhanced platform is designed to compress the lag between a detected supply signal and a coordinated regulatory response, a capability gap that the Visudyne episode exposed clearly. Manufacturers supplying the EU market should anticipate that ESMP-linked reporting obligations will become a standard feature of post-approval supply chain governance.

Once supply is fully restored, EMA will update its shortage catalogue, formally closing the Visudyne entry and providing a documented record of the mitigation measures applied, a reference point for future MSSG assessments and industry contingency submissions.

Source: European Medicines Agency (EMA) via ema.europa.eu, 4 September 2026.