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

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

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

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

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/672442/2015Summary:

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)

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

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

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

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

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

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 closedReference 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