Clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Scientific guideline
This document describes the information to be included when a marketing authorisation application for SCIg/IMIg is made. It addresses biological data, pharmacokinetics, clinical trials and patient follow-up.
Keywords: Immunoglobulin for subcutaneous administration (SCIg), immunoglobulin for intramascular administration (IMIg), human normal immunoglobulin, primary immunodeficiency syndromes, hypogammaglobulinaemia, hepatitis A prophylaxis
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Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 1 (PDF/245.93 KB)
Adopted
First published: 24/07/2015
Last updated: 24/07/2015
Legal effective date: 01/02/2015
EMA/CHMP/BPWP/410415/2011 rev 1 -
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Overview of comments received on 'Guideline on clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration' (PDF/174.88 KB)
First published: 24/07/2015
Last updated: 24/07/2015
EMA/CHMP/BPWP/356919/2013 -
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Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and / or intramuscular administration (SCIg / IMIg) - Revision 1 (PDF/180.57 KB)
Draft: consultation closed
First published: 03/12/2012
Last updated: 03/12/2012
Consultation dates: 03/12/2012 to 03/06/2013
EMA/CHMP/BPWP/410415/2011 Rev 1 -
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Concept paper on revision of note for guidance on the clinical investigation of human normal immunoglobulin for subcutaneous and intramuscular use (CPMP/BPWG/283/00) (PDF/146.28 KB)
Draft: consultation closed
First published: 17/12/2010
Last updated: 17/12/2010
Consultation dates: 16/12/2010 to 31/03/2011
EMA/CHMP/BPWP/761007/2010
- Clinical efficacy and safety: blood products (including biotech alternatives)
- Directive 2001/83/EC
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Good pharmacovigilance practices, module V – risk management systems
- Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)
- Clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg)
- Core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg)
- ICH E3 Structure and content of clinical study reports
- ICH E6 (R1) Good clinical practice
- ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products
- Plasma-derived medicinal products