EMA/HMA recommendations to strengthen supply chain of anti-D immunoglobulins

The European Medicines Agency (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 immunization during pregnancy. RhD immunization happens when a pregnant person with RhD-negative blood type is exposed to RhD-positive blood from their fetus. This can lead to an immune reaction that can seriously impact the health of the fetus, 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 organizations, to support actions to strengthen their availability and prevent serious shortages.