Increase In Antibacterial R&D Prompts EMA Proposal For Improved Guidance

Following a resurgence of activity in the field of antibacterial products, the European Medicines Agency has proposed merging and updating its two existing guidelines on this topic into a single, clearer, core document.

Drugs and bacteria in infinity symbol monochrome concept. Stock vector illustration of pills vs germs, superbug, antibiotics development for company identity in healthcare, medicine and biology.
The EMA's New Antibacterials Guidance Will Be A Single Core Reference Document • Source: Shutterstock

The European Medicines is proposing to update its two existing guidelines on the clinical evaluation of medicines for treating bacterial infections and merge them into a single core document. The new document would clarify, among other things, considerations for the acceptance of single pivotal studies to support infection-site specific indications and pathogen-specific indications.

A draft version of the new guideline is expected to be issued for stakeholder consultation by the fourth quarter of...

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