EMA, FDA and PMDA discuss regulatory approaches for the evaluation of new antibacterial agents
Alignment of data requirements by regulators worldwide can contribute to stimulate the development of new antibiotics to fight antimicrobial resistance and protect global public health, noted the European Medicines agency on a website posting.
However, regulatory activities are only one element of the comprehensive and multifaceted response needed to encourage and accelerate development of new antibacterial medicines that meet patient needs.
This was one of the conclusions reached at a meeting between the EMA, the Japanese Pharmaceutical and Medical Devices Agency and the US Food and Drug, hosted by EMA on 1-2 September 2016.
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