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EMA Antibiotics Guide Seeks To Support Global Development

 
• By Vibha Sharma

The European Medicines Agency has proposed changes to its guideline on the evaluation of new antibacterial medicines so as to align some of the data requirements with those in the US and Japan.

Antimicrobial resistance
EU, US and Japan Are Trying To Converge Requirements For Antibacterials • Source: Shutterstock

The European Medicines Agency is inviting feedback on a draft guideline on antibacterial medicines that has been updated to reflect discussions the agency has had with its regulatory counterparts in the US and Japan on aligning data requirements for the evaluation of such products.

EU, US and Japanese regulators have been holding regular discussions over the past few years on how they might align their approaches for evaluating antibiotics as much as possible and,...

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