UncategorizedAlignment of data requirements to facilitate new antibiotics development

30 נובמבר 20200

EMA, FDA and PMDA held a second tripartite meeting in Vienna on 26-27 April 2017. The main topic were regulatory approaches for the evaluation of antiobacterial agents and differences of data requirements.


It is important to unify requirements in clinical trials industry in order to provide similar requirements for pharmaceutical companies conducting those trials and to allow comparison of results. Such activity lets to develop medications much faster and protects against duplications of studies.

EMA, FDA and PMDA have found areas which do not cover in terms of data requirements for trials of antibiotics and decided to work together to align data requirements for trials of new antibacterial agents. This is intended to stimulate the development of new treatments which will fight antimicrobial resistance.


See more on EMA’s website and check the summary of tripartite meeting.​​​

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