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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Background on the reformIn April 2023, the European Commission (EC) published two proposals to revise the existing (and outdated) pharmaceutical legislation.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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EHA supports the European Medicines Agency's investigation into risk based quality management of clinical trials

EHA has responded to the EMA’s call for comments on the reflection paper on February 15.

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Addressing the bureaucracy challenge

EHA has recently brought key stakeholders around the table to discuss bureaucratic obstacles in clinical research.

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The European Health Data Space Regulation is a reality

The European Health Data Space (EHDS) Regulation has made it to the EU’s Official Journal, almost three years after the initial proposal was published.

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Revising the ICH Guidelines on Clinical Trials

The EHA delegation to the ICH meeting: from left to right, Professors Christian Gisselbrecht, Steven Le Gouill and Martin Dreyling. Clinical trials and drug development have become more complex over the years.

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SWG Educational Activities

General meetings in 2023Meetings to discuss the progress and management of collaborations within the European networks.

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Collaboration with the EMA on Joint Clinical Assessments and Joint Scientific Consultations under the HTA Regulation

The European Hematology Association (EHA) welcomes the draft Implementing Act laying down procedural rules for the exchange of information between the Health Technology Assessment (HTA) Coordination Group, the European Commission, and the European Medicines Agency (EMA).

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