FDA-EMA-PMDA Officials Discuss Convergence on Antibacterial Drugs
Officials from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) met in Tokyo in September to discuss further alignment on clinical trial designs for key indications for antibacterial drugs for which convergence has not yet been reached.Discussions between the three regulators were also expanded to include antifungal agents, an area impacted by antimicrobial resistance, pediatric development of anti-infective products, differences in test methods and criteria for susceptibility testing, as well as clinical trial considerations for new types of treatments, such as monoclonal antibodies, for treating or preventing infectious diseases.
“To facilitate multi-regional anti-infective medicine development, communication and collaboration among scientific and public health bodies involved in such activities are key and options for harmonisation are strongly encouraged,” EMA said in an update on the meeting.
The regulators, who said they will meet again in 2020 and previously met three times in 2016 and 2017, have sought to better align the agencies' expectations for new antimicrobial products so that a single development program could satisfy regulatory requirements for all three jurisdictions.
EMA Update