EMA opens early engagement for antimicrobial developers

The EMA has opened a new system for early dialogue with companies developing medicines for treatment or prevention of infections of bacteria and fungi.

The EMA (European Medicines Agency) has created an Innovation Task Force (ITF) to facilitate early discussions with antimicrobial developers, putting these medicines on the same level as innovative medicines.

The EMA said:

“The ITF will facilitate an early interaction and broad-ranging discussions between innovators and regulatory authorities, which will help developers’ orientation and subsequent use of formal regulatory tools such as EMA’s scientific advice.

“The service is free of charge and any new medicinal product for the treatment of a life-threatening or debilitating fungal or bacterial infection would be considered for discussion in the ITF.”

This shows the importance with which the EMA is treating the threat of antimicrobial resistance (AMR).

Find out more here.

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Published 30. May 2019 in News, News EU