The European Medicines Agency (EMA) has released an addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections for a six-month public consultation period. The addendum provides additional guidance on the requirements for clinical studies related to specific indications and on clinical development programmes for new antibacterial agents targeted against rare or multidrug-resistant pathogens.
Novel antibacterials are needed in order to tackle the growing problem of antimicrobial resistance. The provision of clear guidance for companies is one of the Agency’s key activities in helping to bring these medicines to the market.
The publication of the addendum responds to requests for more detailed guidance on issues such as patient selection criteria and primary endpoints, including efficacy variables and the timing of the assessment of outcomes, made by the pharmaceutical industry and academia during the public consultation on the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections.
As part of the consultation process, the Agency will invite experts in the field for a second workshop on October 25 and 26, 2012 to discuss relevant aspects on the development of new antibacterials that have been addressed in the draft addendum. The workshop will focus on new development pathways for antibacterials targeting multidrug-resistant pathogens.
The comments received during the consultation period and the outcome of the workshop, together with experience gained with novel agents, will allow the refinement of the current text and the release of a consolidated version during 2013.