Non-clinical and clinical development for oral and topical HIV pre-exposure prophylaxis (PrEP) - Scientific guideline
This document aims to highlight regulatory aspects relagarding the preclinical and clinical development of medicinal products used in the pre-exposure prophylaxis of HIV.
Keywords: Human immunodeficiency virus (HIV), prevention, oral pre-exposure prophylaxis (PrEP), topical PrEP
Concept paper on the guidance on the non-clinical and clinical development of medicinal products for HIV prevention including oral and topical PrEP (PDF/86.04 KB)Draft: consultation closed
First published: 24/02/2011
Last updated: 24/02/2011
Consultation dates: 17/02/2011 to 30/04/2011