In response to the discussions at the G7 summits (in Schloss Elmau and Ise-Shima) on the countermeasures taken against antimicrobial resistant infections, EMA, FDA and PMDA held a tripartite face-to-face meeting.
SUMMARY 1 (1 to 2 September 2016, London)
At this meeting, in addition to sharing information on current situation regarding the data requirements for the approval of new antimicrobial agents with limited situation (limited number of patients, limited therapeutic tool, targeting single species etc.), these three regulatory agencies agreed to further promote cooperative discussions which is outlined per attached.
MEETING SUMMARY [41.91KB]
SUMMARY 2 (26 to 27 April 2017, Vienna)
At this meeting, in addition to discussing the data requirements for approval of antimicrobial agents in three regions with a goal of identifying areas for convergence, the three regulatory agencies agreed to continue to work together in order to minimize the impact on clinical development programs, which is outlined per attached.
MEETING SUMMARY [55.80KB]
SUMMARY 3 (24 to 25 October 2017, Kyoto)
The third tripartite meeting yielded significant progress in our discussions on recommended clinical trial designs for evaluating antibacterial drugs and ways to further enhance collaboration in this therapeutic area among the Agencies.
MEETING SUMMARY [45.88KB]
SUMMARY 4 (24 to 25 September 2019, Tokyo)
At the fourth tripartite meeting, significant progress was made in our discussions on recommendations for clinical development of new anti-infective products, acknowledging that considerable convergence has been achieved so far.
MEETING SUMMARY [129.20KB]
The next tripartite face-to-face meeting is scheduled to take place in 2020.
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International Activities