Drug regulators in Europe, the United States and Japan have agreed to align some of their regulations to ease the clinical development of new antibiotics.
The European Medicines Agency, the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency will align certain data requirements to assist the fight against antimicrobial resistance, the EMA announced yesterday.
At a meeting in Vienna on 26 and 27 April, EMA, FDA and PMDA representatives found similarities in their respective clinical trial design regulations, such as patient selection criteria, and agreed to streamline them, the EMA said. The agencies will now update their guidance documents to reflect the agreed areas of convergence, and will issue relevant advice to drug developers.
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