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Introduction
When you visit the EHA website and/or EHA’s resource platform(s) (this includes all websites and pages, with the exemption of www. t2evolve.
Addressing immunoglobulin shortages: EHA and EBA’s strategic recommendations at the EMA
In recent years, shortages of immunoglobulins (Ig) have become a growing concern in the European Union (EU). Since 2018, the European Medicines Agency (EMA)—the EU agency that evaluates and supervises medicines—has received an increasing number of shortage reports.
Read moreImmunoglobulin shortages in the spotlight: EMA, SUPPLY and the SoHO Regulation
EMA executive director Emer Cooke welcoming participants including EHA at the Shortages Workshop, March 1
Shortages of immunoglobulins and the need to increase and sustain plasma supplies have moved to the center of the EU policy and regulatory stage.
EHA in EU-funded project on voluntary plasma collection capacity in Europe
EHA to participate in an EU-funded project on “Strengthening voluntary non-remunerated plasma collection capacity in Europe” (SUPPLY)
Context: Plasma shortage
Plasma-derived medicinal products (PDMPs) are used to treat a variety of rare, chronic, and potentially life-threatening conditions including immune deficiencies, immune-mediated peripheral…
Substances of Human Origin (SoHO) legislation
EHA’s involvementEHA has been involved in both the evaluation and subsequent revision of the EU legislation on human blood and blood components. The evaluation of these rules, which dated back to 2002, began in 2016.
Read moreEvaluation of a single 1.000 mg iron dose as ferric carboxymaltose (FCM) for fatigue treatment in Iron deficient women – PREFER
Fatigue and iron deficiency are prevalent among women of childbearing age. This randomised, placebo-controlled study evaluated the effect of a single intravenous 1.
Read moreStrengthening Resilience and Fostering Collaboration: Ensuring a Transparent and Reliable Supply Chain for Plasma-Derived Products
The issue of immunoglobulin shortages and the importance of enhancing and maintaining plasma supplies have gained significant attention within the policy and regulatory landscape of the European Union.
Read moreThe European Parliament adopts the Regulation on Substances of Human Origins (SoHO)
On April 24, the European Parliament gave its final endorsement to the regulation on Substances of Human Origin (SoHO).
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