Posted by Michael Wonder on 17 Nov 2017
Towards a single development programme for new antibiotics in EU, Japan and US
17 November 2017 - EMA, PMDA and FDA to further align data requirements and explore options to streamline paediatric development.
The EMA, the Japanese Pharmaceuticals and Medical Devices Agency and the United States' FDA have taken further steps to align their approaches to the evaluation of antibiotics, in order to stimulate the development of new treatments to fight antimicrobial resistance and protect global public health.
Representatives of the three regulatory agencies discussed the progress made in their collaboration at a meeting held in Kyoto, Japan, on 24 October 2017. The aim of this collaboration is to facilitate a single development program for new antibacterials that can satisfy the regulatory requirements of each of the three agencies.
