Second tripartite meeting held between EMA, PMDA and FDA to discuss regulatory approaches for the evaluation of antibacterial agents
26/04/2017 to 27/04/2017
Location: Vienna, Austria
The meeting discussed differences between the European Medicines Agency (EMA), the United States (US) Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in their regulatory approaches for evaluating antimicrobial agents, with the aim of identifying areas for convergence. The agencies agreed that some requirements for clinical studies for specific types of infections such as urinary and intra-abdominal infections could be harmonised. The agencies discussed and defined pathways agreeable by the three agencies for the development of new antibacterial agents addressing unmet needs related resulting from antimicrobial resistance. The agencies agreed to hold further discussion in this context as well as other areas. The agencies envisage a third tripartite meeting in October 2017.