EU, US, Japan Further Align Clinical Trial Requirements For Certain New Antibiotics
Executive Summary
To support the development of antibiotics, regulators from the EU, the US and Japan met for the third time in two years and agreed to further align their clinical trial requirements to study the effects of new drugs in certain indications. The initiative was launched in response to increasing global concerns over antimicrobial resistance and the lack of development of new antibiotics.
Regulators in the EU, the US and Japan have made further progress in their ongoing efforts to develop a single development program for new antibiotics. At a recent meeting in Kyoto, there was further alignment between the three regions on how clinical trials should be designed to study the effects of new antibiotics in certain indications, such as uncomplicated gonorrhoea and uncomplicated urinary tract infections.
The three regulators met on Oct. 24 as part of their ongoing efforts to facilitate a single development program for new antibacterials that can satisfy the regulatory requirements of each of the three agencies. This is the third such tripartite meeting under the initiative, with earlier meetings having been held in London in September 2016 and in Vienna in April 2017. (Also see "AMR Threat Prompts EU, US And Japan To Join Forces To Align Data Requirements For New Drug Developers" - Pink Sheet, 13 Jun, 2017.)
At the latest meeting, there was further alignment among the three regulators on a number of clinical trial design elements for key indications for these antibacterial drugs. The importance of adequately characterizing pharmacokinetic and pharmacodynamic relationships, particularly for drugs that are developed to address serious infections with unmet need, was also reiterated.
In addition, the three agencies committed to work together to explore options to better streamline pediatric development of new antibacterial agents. Also, monitoring benefit-risk throughout the lifecycle of a product was recognized as an important activity, particularly for drugs approved on the basis of a more limited clinical program.
Under the initiative, the three agencies plan to meet again in 2018 to further their work on regulatory convergence.
From the editors of Scrip Regulatory Affairs.