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

Current effective version

Reflection paper on the non-clinical and clinical development for oral and topical HIV pre-exposure prophylaxis (PrEP)

Draft: consultation closed Consultation dates: 15/03/2012 to 30/06/2012 Reference Number: EMA/171264/2012 Summary:

The purpose of this reflection paper is to highlight regulatory aspects regarding the preclinical and clinical development of HIV pre-exposure prophylaxis, so that applicants are prepared to address these issues in their future applications.

Document history

Concept paper on the guidance on the non-clinical and clinical development of medicinal products for HIV prevention including oral and topical PrEP

Draft: consultation closed Consultation dates: 17/02/2011 to 30/04/2011 Reference Number: EMA/86004/2011