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AMR Threat Prompts EU, US And Japan To Join Forces To Align Data Requirements For New Drug Developers

 
• By Neena Brizmohun

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.

Antibiotic resistant bacteria closeup biofilm
EU, US and Japanese regulators have joined force in the fight against antimicrobial resistance

Drug regulators in the EU, US and Japan have agreed to align their data requirements for certain aspects of the clinical development of new antibiotics in a bid to stimulate the development of new treatments to fight antimicrobial resistance and protect global public health.

The move is designed to respond to increasing global concerns over antimicrobial resistance (AMR) and the lack of development of new antibiotics.

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