New guidance to speed up development of antibiotics


28 September 2015 - The European Medicines Agency (EMA) has released a draft guideline for public consultation on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics. The document provides guidance for the conduct of robust analyses to facilitate and speed up the development of new antibiotics, in particular those targeting multi-drug resistant bacteria. Comments on this draft guideline should be sent to using the form provided, no later than 31 March 2016.

The increasing emergence of bacteria that have become resistant to a wide range of antibiotics is a major and global public health issue. On the one hand it is essential to encourage the prudent use of antibiotics so that development of antimicrobial resistance can be reduced to a minimum, on the other hand new antibiotics are urgently needed for the treatment of serious infectious diseases, in particular when patients have very limited or no remaining treatment options. A central pillar in EMA’s strategy to fight antimicrobial resistance is to offer an environment that stimulates and facilitates development of innovative antibiotics.

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Michael Wonder

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Michael Wonder