Carcinogenicity evaluation of medicinal products for the treatment of HIV infection - Scientific guideline

This document provides guidance on carcinogenicity studies that should be conducted during development and before marketing authorisation for any new anti-HIV medicinal product, if applicable. It also assists with describing this non-clinical information in the summary of products characteristics.

Keywords: Anti-HIV compounds, NRTI's, NNRTI's, protease inhibitors, genotoxic properties, carcinogenicity timing

Current effective version

Guideline on carcinogenicity evaluation of medicinal products for the treatment of HIV infection

Adopted Reference Number: EMEA/CHMP/SWP/194898/2006 Legal effective date: 01/07/2008

Document history - First version (current)

Guideline on carcinogenicity evaluation of medicinal products for the treatment of HIV infection

Adopted Reference Number: EMEA/CHMP/SWP/194898/2006 Legal effective date: 01/07/2008

Overview of comments received on draft guideline on carcinogenicity evaluation of medicinal products for the treatment of HIV infection

Reference Number: EMEA/211762/2007

Draft guideline on carcinogenicity evaluation of medicinal products for the treatment of HIV infection

Draft: consultation closed Consultation dates: 27/07/2006 to 31/01/2007 Reference Number: EMEA/CHMP/SWP/194898/2006