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Tripartite Meeting held between EMA, FDA and PMDA towards enhancing development for Antibacterial Agents

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.
 

  Date
Location
SUMMARY
1

1-2 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
 
2

26-27 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
 
3

24-25 Oct 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
 


The next tripartite face-to-face meeting is scheduled to take place in 2018.
 


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JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan

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Tripartite Meeting held between EMA, FDA and PMDA towards enhancing development for Antibacterial Agents
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