MedWatch

EMA publishes new plan to support antibiotic development

Drug-resistant bacteria kill hundreds of thousands of people every year, and national regulatory forces across the world are now coming together to ensure a uniform approach to clinical trials for antibiotics.

Photo: Peter Dejong/AP/Ritzau Scanpix

The European Medicines Agency (EMA) has a plan to address the increasingly pressing challenge of antibiotic-resistant bacteria, the EMA reports in a news release on its website.

The plan is geared toward running clinical studies that target the discovery of new antibiotics, as the EMA recognizes that antibiotic-resistant bacteria are a global threat. For these reasons, the EMA has joined forces with regulatory authorities from the US and Japan to align respective data requirements as much as possible, allowing antibiotic makers to design clinical trials that fulfill evidence needs of several agencies at once.

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