Posted by Michael Wonder on 12 Jun 2017
Regulators in EU, Japan and US take steps to facilitate development of new antibiotics
12 June 2017 - EMA, PMDA and FDA align data requirements and agree on areas of convergence.
The EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States' FDA have agreed to align their data requirements for certain aspects of the clinical development of new antibiotics in order to stimulate the development of new treatments to fight antimicrobial resistance and protect global public health.
Representatives from the three regulatory agencies met in Vienna on 26-27 April 2017 and discussed recommendations for the design of clinical trials that test new treatments for certain types of bacterial infections, including infections caused by multi-drug resistant organisms. They identified a number of areas where the data requirements in the three regions could be streamlined.
