Back European anti-D plasma collection programmes – Key technical report published by the CD-P-TS

EDQM Strasbourg, France 27/03/2026
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European anti-D plasma collection programmes – Key technical report published by the CD-P-TS

A pivotal technical report, “Can we have European anti-D plasma collection programmes?”, has just been released by the European Committee on Blood Transfusion (CD-P-TS), an intergovernmental committee co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM). The report addresses the need to (re-)establish anti-D plasma collection programmes within Europe. Anti-D immunoglobulin (IgG) remains essential for preventing haemolytic disease of the foetus and newborn (HDFN) and is the only effective prophylactic treatment for pregnant women at risk of RhD alloimmunisation in Europe. However, almost all anti-D IgG used in Europe is sourced from plasma collected in the United States – a structural vulnerability highlighted by the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) in their 2025 recommendations.

Drawing on survey findings, international expert consultations and case studies from Europe, Australia and the United States, the CD-P-TS report outlines technical, regulatory and operational pathways for building sustainable anti-D plasma collection capabilities at national and pan-European levels. The report identifies several key priorities:

  • developing a European roadmap to support the (re-)establishment of anti-D plasma collection programmes, including donor identification, immunisation and collection protocols;
  • supporting the establishment of European plasma pooling approaches to enable efficient and sustainable manufacture;
  • encouraging dedicated policy and financial support from Council of Europe member states and European institutions;
  • promoting optimisation of clinical use through wider implementation of foetal RhD genotyping and appropriate dosing strategies;
  • supporting research and development of sustainable alternative therapeutic approaches.

Securing a resilient, European-based supply of anti-D IgG is a public health priority to safeguard maternal and neonatal health across the continent. The initiatives outlined in the CD-P-TS report, supported by ongoing scientific, technical and policy action, provide a roadmap for Europe to regain strategic independence and build long-term sustainability in this essential area of care.

For more details and additional resources, visit the dedicated EDQM web page on anti-D immunoglobulin.

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