Regulatory Focus™ > News Articles > EMA Releases Draft Guidance on HIV Prophylaxis

EMA Releases Draft Guidance on HIV Prophylaxis

Posted 15 March 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) released new reflection paper 15 March on the development of pre-exposure prophylaxis (PrEP) products for Human Immunodeficiency Virus (HIV).

The paper, intended for pharmaceutical companies, aims to assist in the development of oral and topical medications to be used as part of an integrated risk-reduction approach.

"This reflection paper sets out a consolidated position based on this research, which has culminated in the positive results of two studies using anti-HIV medicines to reduce the likelihood of catching HIV," wrote EMA.

The consultation paper incorporates comments received on an earlier concept paper released lat year, as well as a workshop hosted last year.

"The Agency is continuing to follow scientific developments in this area, giving scientific advice as requested and following consultations that culminated in this reflection paper. The paper states that the Agency is prepared to evaluate future marketing authorisation applications for PrEP," wrote EMA.

Read more:

EMA - European Medicines Agency issues guidance on prevention of HIV transmission for public consultation

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

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