Alignment of data requirements to facilitate new antibiotics development
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.
Those three agencies will update quideline documents to streamline data that will be have to be provided in order to conduct a trial. The main changes will be provided in treatment of certain types of bacterial infections such as caused by multi-drug resistant organisms.