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Revision of the EU’s pharmaceutical legislation

Background on the reformIn April 2023, the European Commission (EC) published two proposals to revise the existing (and outdated) pharmaceutical legislation. This includes legislation on medicines for children and rare diseases.

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EU Parliament agrees on pharmaceutical legislation stance

On April 10, the European Parliament adopted its position on the revision of the EU pharmaceutical legislation.

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The 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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Clinical trials

The advance of highly innovative, increasingly personalized therapies in hematology requires novel clinical trial designs and more flexible, adaptive regulatory frameworks and improved data generation to support decision making both during and after clinical studies.

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Advocacy priorities

The European Union works on countless pieces of legislation and policies that affect the health ecosystem. Some are relevant to most medical disciplines, including hematology—such as the legislation on health data or pharmaceuticals.

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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.

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How to apply for an EHA Research Grant

On this page, we explain all of the actions you'll need to take when submitting a grant application. You can also get a basic overview of the process in our EHA Research Grants diagram.

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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.

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EHA-AAH joint membership

Save money and time by becoming a joint member of EHA and the Albanian Association of Hematology. We've joined forces with the Albanian Association of Hematology (AAH) to offer a special joint membership deal.

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