AMR Threat Prompts EU, US And Japan To Join Forces To Align Data Requirements For New Drug Developers
EU, US and Japanese regulatory agencies will provide advice to developers of antibiotics that is consistent with the agreements they have reached on aligning their data requirements.
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Following a resurgence of activity in the field of antibacterial products, the European Medicines Agency has proposed merging and updating its two existing guidelines on this topic into a single, clearer, core document.
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.
Regulatory incentives have been successful at attracting developers to antibiotic R&D, but significant medical advances have stubbornly remained rare. Now the pipeline has produced the first novel antibiotic to receive breakthrough status from US FDA and some Phase III trials are raising the efficacy bar to superiority.