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EMA: Recommendations on strengthening the supply chain of anti-D immunoglobulins

4 July 2025

EMA: Recommendations on strengthening the supply chain of anti-D immunoglobulins

The European Medicines Agency (EMA) and the Heads of Medicines agencies (HMA) have, through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.

When a pregnant person with Rhesus (RhD)-negative blood type is exposed to RhD-positive blood from their foetus, this results in a RhD immunisation. Currently, the only available treatment for the prevention of RhD immunisation during pregnancy is anti-D immunoglobulins, which are collected by blood donations. Because the numbers of donors are declining, EU Member States are recommended to create plans to secure the supply of anti-D immunoglobulins. These plans should be guided by relevant safety, legal, ethical and regulatory aspects and focus on reducing unnecessary use. Additionally, countries should support development and validation of alternatives to these medicines through research and funding and create prioritisation guidelines to manage shortages.

For more information, see here.

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