Development of new antibiotics: Europe, US and Japan agree on joint action

A meeting between the European Medicines Agency, FDA and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) was held in the last few days to discuss regulatory approaches for the evaluation of antibacterial agents. A shared regulatory approach is considered a valid contribution to the development of new antibiotics, which is proving more and more fundamental to fight resistance and protect global public health. Despite of the conclusion, the Agencies consider this just one of the necessary elements in this process. They also agreed that some flexibility should be applied to clinical development programs for new antibiotics, in particular where treatment options for patients are limited due to bacterial resistance. In addition to such flexibility, it could be necessary to use short clinical development programs and to include shared approaches to clinical trial design, choice of endpoints, as well as post-authorization monitoring activities for these drug classes. The conclusions of the meeting will be presented at the G7 Health Ministers’ meeting, organized by the government of Japan on 11-12 September.
(Source EMA)