Tripartite meeting between EMA, PMDA and FDA on regulatory approaches for the evaluation of antibacterial agents
01/09/2016 to 02/09/2016
Location: European Medicines Agency, London, United Kingdom
The European Medicines Agency (EMA), the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) met to discuss how the three regulators can facilitate the development of safe and effective antibacterial medicines. The initiative responds to increasing global concerns over antimicrobial resistance and the lack of development of new antibiotics. The objective is to map existing similarities and differences in requirements in the three regions, and work towards constructive proposals for further convergence.