7 September 2016 - EMA, FDA and PMDA discuss regulatory approaches for the evaluation of new anti-bacterial agents.
Alignment of data requirements by regulators worldwide can contribute to stimulate the development of new antibiotics to fight antimicrobial resistance and protect global public health. However, regulatory activities are only one element of the comprehensive and multifaceted response needed to encourage and accelerate development of new antibacterial medicines that meet patient needs.
This was one of the conclusions reached at a meeting between the EMA, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States' FDA hosted by EMA on 1-2 September 2016.
At their tripartite meeting, the three agencies also agreed that some flexibility should be applied to the requirements for clinical development programmes for antibacterial agents, in particular where treatment options for patients are limited due to antimicrobial resistance.