EMA Releases Opinion on Antimicrobial Use Under the Cascade

The European Medicines Agency (EMA) has published its highly anticipated scientific opinion regarding using antimicrobials under the cascade system. The opinion establishes a comprehensive list of antimicrobials that should only be utilized within the terms of their marketing authorization or that may only be used under specific conditions.

This exhaustive 358-page review encompasses various antimicrobials, carefully considering the risks associated with antimicrobial resistance (AMR) in relation to both animal and human health while also exploring the availability of alternative treatment options.

The EMA’s recommendation does not propose a complete exclusion of any antimicrobials from use under the cascade. However, it does suggest certain restrictions for specific antimicrobials, such as fluoroquinolones, polymyxins, and 3rd and 4th generation cephalosporins. These restrictions aim to balance the need for effective treatment while mitigating the risks of AMR.

The next step involves the European Commission drafting an implementing act, which will then be discussed with experts from member states. Their input and collaboration will be vital in shaping the final regulations.

The complete EMA opinion can be accessed HERE for those interested in delving deeper into the details. This marks a significant milestone in the ongoing efforts to promote responsible and effective antimicrobial use within the European Union.


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