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Europa English European Agencies EMA
04.07.2025
News
Strengthening supply chain of anti-D immunoglobulins
EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.
These medicines are currently the only available treatment for the prevention of RhD immunisation during pregnancy. RhD immunisation happens when a pregnant person with RhD-negative blood type is exposed to RhD-positive blood from their foetus. This can le...
EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins. These medicines are currently the only available treatment for the prevention of RhD immunisation during pregnancy. RhD immunisation happens when a pregnant person with RhD-negative blood type is exposed to RhD-positive blood from their foetus. This can lead to an immune reaction that can seriously impact the health of the foetus, and later of the newborn, and have potentially fatal outcomes. Plasma, the liquid part of blood, collected from donors and containing the anti-D immunoglobulin is currently the only source for manufacturing these medicines. The numbers of donors are declining, and anti-D immunoglobulins are only produced in a limited number of countries, all located outside the European Union (EU). For this reason, the MSSG has been monitoring the supply chain of these medicines and has issued these recommendations to national regulators, the European Commission, as well as to the plasma industry and relevant research organisations, to support actions to strengthen their availability and prevent serious shortages. EU Member States are recommended to create plans to secure the supply of anti-D immunoglobulins in the EU, guided by relevant safety, legal, ethical and regulatory aspects. These plans should also focus on reducing...
Errors and omissions excepted. As of: 04.07.2025