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

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

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

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

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

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 closedConsultation dates: 03/12/2012 to 03/06/2013Reference Number: EMA/CHMP/BPWP/410415/2011 Rev 1Summary:

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 closedConsultation dates: 16/12/2010 to 31/03/2011Reference 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)

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