Clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Scientific guideline

This guideline 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: SCIg, IMIg, human normal immunoglobulin, primary and secondary immunodeficiency syndromes, hepatitis A prophylaxis, immunomodulation, chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

Current effective version - under revision

Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 1

Adopted Reference Number: EMA/CHMP/BPWP/410415/2011 rev 1 Legal effective date: 01/02/2015 Summary:

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 biological data, clinical trials and patient follow-up. Quality aspects are outside the scope of this guideline. Guidance is also provided for authorised products where a significant change in the manufacturing process has been made.

Revision 2

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

Draft: consultation closed Consultation dates: 05/12/2024 to 13/06/2025 Reference Number: EMA/CHMP/BPWP/496692/2023 rev 2 Summary:

This guideline replaces guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 1.

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Revision 1

Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 1

Adopted Reference Number: EMA/CHMP/BPWP/410415/2011 rev 1 Legal effective date: 01/02/2015 Summary:

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 biological data, clinical trials and patient follow-up. Quality aspects are outside the scope of this guideline. Guidance is also provided for authorised products where a significant change in the manufacturing process has been made.

Overview of comments received on 'Guideline on clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration'

Reference Number: EMA/CHMP/BPWP/356919/2013

Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and / or intramuscular administration (SCIg / IMIg) - Revision 1

Draft: consultation closed Consultation dates: 03/12/2012 to 03/06/2013 Reference Number: EMA/CHMP/BPWP/410415/2011 Rev 1 Summary:

This guideline describes the information to be documented when an application is made for a marketing authorisation for a human normal immunoglobulin for subcutaneous or intramuscular use (SCIg / IMIg). The guidance covers biological data, clinical trials and patient follow-up. Guidance is also provided for authorised products where a significant change in the manufacturing process has been made.

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)

Draft: consultation closed Consultation dates: 16/12/2010 to 31/03/2011 Reference Number: EMA/CHMP/BPWP/761007/2010

First version

Note for guidance on the clinical investigation of human normal immunoglobulin for subcutaneous and intramuscular (CPMP/BPWG/283/00)

Adopted Reference Number: EMEA/CPMP/BPWG/283/00 Legal effective date: 01/01/2003