European Medicines Agency addresses development of new antibacterials
The European Medicines Agency has published a report summarising the discussions at its workshop on antibacterials, held in London in February 2011.
The workshop covered issues including how new medicines to treat infections with bacteria resistant to many other antibiotics should be evaluated and how studies should be designed. The workshop also looked at how antibiotics against various specific types of infection should be tested, including pneumonia, complicated infections of the skin and soft tissue, bronchitis, sinusitis and blood infection.
The workshop brought together academics, regulators and representatives of the pharmaceutical industry, to discuss the ongoing revision of the Agency's guideline on the evaluation of medicinal products indicated for treatment of bacterial infections . This guideline, which was released for public consultation between March and August 2010, aims to provide guidance to companies developing antibacterial medicines, covering how they should carry out studies to test these medicines' benefits and risks.
The views expressed in the report are the personal views of the experts who participated. The Agency's official position will be reflected in the revised version of the guideline, which it expects to adopt by the end of June 2011.