Non-clinical and clinical development for oral and topical HIV pre-exposure prophylaxis (PrEP)

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Current version

Draft reflection paper

Reference numberEMA/171264/2012
Published15/03/2012
KeywordsHuman immunodeficiency virus (HIV), prevention, oral pre-exposure prophylaxis (PrEP), topical PrEP
DescriptionThis document aims to highlight regulatory aspects relagarding the preclinical and clinical development of medicinal products used in the pre-exposure prophylaxis of HIV.


Document history

First version

Current version

Draft reflection paper


Concept paper

Published: 15/03/2012


Published: 24/02/2011


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