Towards a single development programme for new antibiotics in EU, Japan and US

News 17/11/2017

EMA, PMDA and FDA to further align data requirements and explore options to streamline paediatric development

The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States' Food and Drug Administration (FDA) have taken PDF icon 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.

At the Kyoto meeting, the three agencies agreed to further align how clinical trials should be designed to study the effects of new antibiotics in certain indications, such as uncomplicated gonorrhoea or uncomplicated urinary tract infections. Stressing the importance of gathering meaningful clinical data in children, they also committed to working together to explore how to better streamline paediatric development of new antibacterial agents.

This was the third tripartite meeting held between the three agencies, after an initial meeting that took place at EMA in September 2016 and a tripartite meeting held in Vienna in April 2017, to identify areas for convergence of regulatory requirements for antimicrobial agents. These talks take place under the terms of the respective confidentiality agreements of the three agencies.

Stimulating and facilitating the development of new antibiotics, in particular those targeting multidrug-resistant pathogens, is among the European Commission's priorities and an important part of EMA's contribution to fight antimicrobial resistance.

EMA supports European Antibiotic Awareness Day on 18 November 2017 which calls for responsible action from all citizens to #KeepAntibioticsWorking.

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