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
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Guideline on the clinical development of medicinal products for the treatment of HIV infection - Revision 3 (PDF/212.69 KB)
Adopted
First published: 11/07/2016
Last updated: 11/07/2016
Legal effective date: 01/01/2017
EMEA/CPMP/EWP/633/02 Rev. 3 -
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Overview of comments received on 'Guideline on the clinical development of medicinal products for the treatment of HIV infection' (PDF/269.98 KB)
First published: 12/07/2016
Last updated: 12/07/2016
EMA/CHMP/EWP/672442/2015 -
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Draft guideline on the clinical development of medicinal products for the treatment of human-immunodeficiency-virus (HIV) infection (revision 3) (PDF/257.74 KB)
Draft: consultation closed
First published: 30/09/2013
Last updated: 07/10/2013
Consultation dates: 30/09/2013 to 31/03/2014
EMEA/CPMP/EWP/633/02 Rev. 3 -
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Concept paper on the update of guidance on the clinical development of medicinal products for the treatment of HIV (PDF/136.79 KB)
Draft: consultation closed
First published: 15/11/2011
Last updated: 15/11/2011
Consultation dates: 20/10/2011 to 31/01/2012
EMA/802793/2011
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Guideline on the clinical development of medicinal products for the treatment of HIV infection - Revision 2 (PDF/207.55 KB)
Adopted
First published: 20/11/2008
Last updated: 20/11/2008
Legal effective date: 01/06/2009
EMEA/CPMP/EWP/633/02 Rev. 2 -
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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 (PDF/420.01 KB)
First published: 04/02/2009
Last updated: 04/02/2009
EMEA/301021/2008 -
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Draft guideline on the clinical development of medicinal products for the treatment of HIV infection (Rev.2) (PDF/102.06 KB)
Draft: consultation closed
First published: 18/10/2007
Last updated: 18/10/2007
EMEA/CPMP/EWP/633/02 Rev. 2 -
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Annex A - Clinical Development of Medicinal Products for Treatment of HIV Infection (PDF/30.4 KB)
First published: 22/02/2007
Last updated: 22/02/2007
EMEA/CHMP/EWP/42065/2007 -
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Annex B - Clinical Development of Medicinal Products for Treatment of HIV Infection (PDF/34 KB)
First published: 22/02/2007
Last updated: 22/02/2007
EMEA/CHMP/EWP/42065/2007
- Clinical efficacy and safety: anti-infectives for systemic use
- Directive 2001/83/EC
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Exposure to medicinal products during pregnancy: need for post-authorisation data
- Choice of the non-inferiority margin
- Clinical development of fixed combination medicinal products
- Evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function
- Evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function
- ICH E11 Clinical investigation of medicinal products in the paediatric population
- Investigation of drug interactions
- Pharmacokinetic studies in man
- Role of pharmacokinetics in the development of medicinal products in the paediatric population