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EMA – EMA workshop on the challenges in drug development, regulation and clinical practice for immunoglobulins held on 5 March 2025: publication of the workshop’s report

Immunoglobulins were first used as replacement therapy in patients with humoral immunodeficiency and are now used for both primary immunodeficiencies (PID) and several secondary immunodeficiencies. They are also used for immunomodulatory indications in patients with primary immune thrombocytopenia (ITP), Guillain-Barré syndrome (GBS), Kawasaki’s disease, multifocal motor neuropathy (MMN), and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

The European Medicines Agency (EMA) has published guidelines for the clinical investigation of human normal immunoglobulin for intravenous use with regards to the use of immunoglobulins in CIDP and GBS.1,2 Following the release for public consultation of the EMA guideline on the core summary of product characteristics (SmPC) for subcutaneous and intramuscular human normal immunoglobulin medicines, EMA organised a virtual workshop to get perspectives of stakeholders on use of immunoglobulins in both established and new indications as well as the data needed and clinical requirements for the marketing authorisation of these products.

The virtual workshop, held on 5 March 2025, was attended by healthcare professionals, industry and health technology assessment (HTA) bodies. This report summarises the key aspects discussed and the views expressed should not be understood as being the official views of EMA or its scientific committees.

The report of the workshop, as well as the presentation materials and the video recordings of the event are available on the EMA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (11 décembre 2025). EMA – EMA workshop on the challenges in drug development, regulation and clinical practice for immunoglobulins held on 5 March 2025: publication of the workshop’s report. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/15bv6


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