Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Scientific guideline

This guidance describes the information to be documented when a marketing authorisation application is made for IVIg. It covers biological data, clinical trials and patient follow-up.

Keywords: Intravenous immunoglobulin (IVIg), primary immunodeficiency syndromes, hypogammaglobulinaemia, primary immune thrombocytopenia, idiopathic thrombocytopenic purpura (ITP), Guillain Barré syndrome, Kawasaki disease, multifocal motor neuropathy (MMN), chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), myasthenia gravis exacerbations

Current effective version

Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - rev. 4

Adopted Reference Number: EMA/CHMP/BPWP/94033/2007 rev. 4 Legal effective date: 01/01/2022

Document history - Revision 4

Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Rev. 4

Draft: consultation closed Consultation dates: 13/10/2020 to 13/01/2021 Reference Number: EMA/CHMP/BPWP/94033/2007 Rev.4

Overview of comments received on Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) (EMA/CHMP/BPWP/94033/2007 rev. 4)

Reference Number: EMA/20937/2021

Document history - Revision 3

Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Rev. 3

Adopted Reference Number: EMA/CHMP/BPWP/94033/2007 Rev. 3 Legal effective date: 01/01/2019

Overview of comments received on ‘the guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)’ (EMA/CHMP/BPWP/94033/2007), Rev.3

Reference Number: EMA/CHMP/BPWP/604687/2009

Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Revision 3

Draft: consultation closed Consultation dates: 01/01/2017 to 31/03/2017 Reference Number: EMA/CHMP/BPWP/94033/2007 Rev. 3 Summary:

This Guideline describes the information to be documented when an application is made for a marketing authorisation for a human normal immunoglobulin for intravenous use (IVIg). The guidance covers biological data, clinical trials and patient follow-up. Quality aspects are outside the scope of this guideline.

Draft concept paper on guideline on the clinical investigation of human normal immunoglobulin for intravenous administration and core summary of product characteristics

Draft: consultation closed Consultation dates: 01/08/2014 to 31/10/2014 Reference Number: EMA/CHMP/BPWP/572805/2013 Summary:

The current note for guidance on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg, EMA/CHMP/BPWP/94033/2007 revision 2) and the core summary of product characteristics (SmPC) for human normal IVIg (CHMP/BPWP/94038/2007 revision 4) have been in operation since December 2000 and underwent a major revision process from 2006 to 2010. The question arises whether the guideline and the core SmPC should be updated to include chronic inflammatory demyelinating polyradiculoneuropathy and multifocal motor neuropathy as being 'established indications'. Additionally, some international experts recommend that dosing in replacement therapy and in.immunomodulation should be re-evaluated, possibly with adjustment according to lean body weight.

Document history - Revision 2

Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Revision 2

Adopted Reference Number: EMA/CHMP/BPWP/94033/2007 rev. 2 Legal effective date: 01/02/2011

Overview of comments received on the guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg): (EMA/CHMP/BPWP/94033/2007, rev. 2 formerly CPMP/BPWG/388/95 rev. 2)

Reference Number: EMA/CHMP/BPWP/604687/2009

Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Revision 2

Draft: consultation closed Reference Number: EMA/CHMP/BPWP/94033/2007 rev. 2

Document history - Revision 1

Concept paper on revision of: Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg) and on the Core SPC for Human Normal l Immunoglobulin for Intravenous Administration (IVIg) - Revision 1

Reference Number: EMEA/CHMP/BPWG/151426/2004