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EMA – Consultation on Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) – Revision 2

The draft of the new version of the Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) has been published for consultation. Interested contributors have until 31 May to comment.

This guideline describes the information to be documented when an application is made for a marketing authorisation for a human normal immunoglobulin for subcutaneous and/or intramuscular use (SCIg/IMIg). The guidance covers clinical trials and patient follow-up.

This is the second revision of the Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg). It replaces version 1 and updates the guideline to be consistent where applicable with the revised guideline for human normal immunoglobulin for intravenous administration (IVIg) (EMA/CHMP/BPWP/94033/2007 current version). It clarifies the indication wording of secondary immunodeficiencies (SID) and includes the indication for maintenance treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (5 février 2025). EMA – Consultation on Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) – Revision 2. ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/13918


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