Clinical development of medicinal products for treatment of HIV infection - Scientific guideline

This document provides guidance on the clinical development of medicinal products for the treatment of HIV infection. It also concern the requirements for authorisation and wording of the summary of products characteristics.

Keywords: Human immunodeficiency virus (HIV), HIV infection, acquired immune-deficiency syndrome (AIDS), anti-retroviral therapy

Current effective version

Guideline on the clinical development of medicinal products for the treatment of HIV infection - Revision 3

Adopted Reference Number: EMEA/CPMP/EWP/633/02 Rev. 3 Legal effective date: 01/01/2017 Summary:

This document provides guidance on the clinical development of direct-acting antiretroviral agents for the treatment of HIV infection.

Document history - Revision 3 (current)

Guideline on the clinical development of medicinal products for the treatment of HIV infection - Revision 3

Adopted Reference Number: EMEA/CPMP/EWP/633/02 Rev. 3 Legal effective date: 01/01/2017 Summary:

This document provides guidance on the clinical development of direct-acting antiretroviral agents for the treatment of HIV infection.

Overview of comments received on 'Guideline on the clinical development of medicinal products for the treatment of HIV infection'

Reference Number: EMA/CHMP/EWP/672442/2015 Summary:

Overview of comments received on 'Guideline on the clinical development of medicinal products for the treatment of HIV Infection’ (EMEA/CPMP/EWP/633/02 Rev. 3)

Draft guideline on the clinical development of medicinal products for the treatment of human-immunodeficiency-virus (HIV) infection (revision 3)

Draft: consultation closed Consultation dates: 30/09/2013 to 31/03/2014 Reference Number: EMEA/CPMP/EWP/633/02 Rev. 3 Summary:

This guideline provides guidance on the clinical development of direct-acting antiretrovirals for the treatment of human-immunodeficiency-virus (HIV) infection. It replaces EMEA/CPMP/EWP/633/02 Rev 2.

Concept paper on the update of guidance on the clinical development of medicinal products for the treatment of HIV

Draft: consultation closed Consultation dates: 20/10/2011 to 31/01/2012 Reference Number: EMA/802793/2011 Summary:

It is anticipated that updated guidance will facilitate the development of new antiretroviral therapies, especially those

suitable for patients infected with virus that cannot be adequately treated using currently licensed

agents.

Document history - Revision 2

Guideline on the clinical development of medicinal products for the treatment of HIV infection - Revision 2

Adopted Reference Number: EMEA/CPMP/EWP/633/02 Rev. 2 Legal effective date: 01/06/2009

Overview of comments received on the draft revision of the guideline on the clinical development of medicinal products for the treatment of HIV infection - EMEA/CPMP/EWP/633/02 Rev. 2

Reference Number: EMEA/301021/2008

Draft guideline on the clinical development of medicinal products for the treatment of HIV infection (Rev.2)

Draft: consultation closed Reference Number: EMEA/CPMP/EWP/633/02 Rev. 2

Annex A - Clinical Development of Medicinal Products for Treatment of HIV Infection

Reference Number: EMEA/CHMP/EWP/42065/2007

Annex B - Clinical Development of Medicinal Products for Treatment of HIV Infection

Reference Number: EMEA/CHMP/EWP/42065/2007