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Immunoglobulin 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.

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New HemaSphere publication on IVDR implementation

The In Vitro Diagnostic medical devices Regulation (IVDR), which came in to force in May 2022 with the objective of safeguarding the quality and safety of diagnostic tests in the EU, has a major impact on commercially available IVDs (CEIVDs) and…

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EHA Statement of Solidarity with local communities in Türkiye and Syria

The European Hematology Association (EHA) is deeply concerned about the situation in southern Türkiye and northern Syria: Monday's earthquakes and aftershocks have killed thousands of people and destroyed innumerable buildings, while freezing temperatures and damaged roads are hampering rescue efforts.

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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…

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New EU In Vitro Diagnostic medical devices Regulation (IVDR) comes into effect

On May 26, 2022, the new EU In Vitro Diagnostic medical devices Regulation (IVDR) came into effect, mandating stricter and more comprehensive certification and testing protocols for in vitro diagnostic medical devices.

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EHA Statement of Solidarity with Ukraine

The European Hematology Association (EHA) is deeply concerned about the situation in Ukraine, the plight of the civilian population, and the damage to healthcare infrastructures.

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