The European Medicines Agency (EMA) has launched a consultation to guide its efforts in revising its guideline on the evaluation of human medicines indicated for the treatment of bacterial infections. The current draft has been released for the benefit of stakeholders, and has also been adopted by the Committee for Human Medicinal Products (CHMP).
Explaining the need for new guidance, the EMA say:
“Antimicrobial resistance is a global public health problem. Regulators in the European Union, the United States and Japan have had extensive discussions over the last few years to explore and agree how to align as much as possible their respective data requirements so that medicine developers can design clinical trials that meet the evidence needs of multiple regulatory agencies. The revised guidance reflects the outcome of these discussions.
“In addition, it offers clarification on the clinical development of antibacterial agents that are expected to address an unmet medical need, in accordance with experience gained from previous regulatory decisions.
“Specific advice has also been added with regards to the EU regulatory requirements to develop medicines for the treatment of uncomplicated urinary tract infections and gonorrhoea.”
To track the consultation on MAP’s pages, click here.