EMA Issues Recommendations to Strengthen Anti-D Immunoglobulin Supply

The European Medicines Agency (EMA) and the Heads of Medicines Agencies issued new recommendations last week to address vulnerabilities in the supply chain of anti-D immunoglobulins. The recommendations, developed by the Executive Steering Group on Shortages and Safety of Medicinal Products, come in response to a declining number of plasma donors in the European Union (EU) and the lack of manufacturers inside the EU.

The agencies called on EU member states to develop national plans to secure the supply of anti-D immunoglobulins and reduce unnecessary use of the product. In addition, the EMA recommended that member states support the development of alternative therapies and diagnostics through research and funding, create guidelines to manage shortages and promote public awareness of plasma donation to produce plasma-derived medicines.

Furthermore, the EMA advised the European Commission to coordinate member states’ efforts and to leverage the proposed Critical Medicines Act to establish or increase supply of anti-D immunoglobulins in the EU. The recommendations also encourage the plasma industry to invest in manufacturing optimization and explore alternatives to plasma-derived anti-D immunoglobulins.