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Global regulators align to assist antibiotic development in AMR climate

By Flora Southey , 13-Jun-2017
Last updated on 13-Jun-2017 at 14:23 GMT2017-06-13T14:23:49Z

iStock/ayo888
iStock/ayo888

Regulators in Europe, Japan and the US say they have aligned clinical data requirements for new antibiotics to encourage industry to develop drugs for infections caused by resistant bacteria.

Representatives from the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the US Food and Drug Administration (FDA) met last month to discuss recommendations for clinical trial processes.

The government bodies have agreed to align data requirements for certain aspects of the clinical development of treatments for bacterial infections, including those caused by resistant organisms.  

The EMA said several aspects of clinical development have been identified, but did provide details.

The regulators first met in September last year to discuss the development of new antibiotics, and will meet again in October.

Antimicrobial resistance

Antimicrobial resistance (AMR) is resistance of a microorganism to an antimicrobial medicine.

Resistant organisms are not affected by antimicrobial medicines such as antibiotics.

As a consequence, medicines are no longer effective and infections persist in the body, which increases the risk of spreading the infection to others.

A call for action

European health organisations, including the European Public Health Alliance (EPHA) and Health Action International, are also in discussions regarding the threat of antimicrobial resistance.

In a letter published last week to president of the European Commission, Jean-Claude Juncker, representatives from the EPHA and European Patients Forum called for cross-country collaboration.

“Antimicrobial resistance is taking hold more rapidly around the world than expected. No single country can tackle that challenge alone. Bacteria and drug resistance cannot be stopped by borders,” said the representatives.

“National governments cannot address the threats to health and health services alone. We face common challenges from drug-resistant infections…that can be tackled together far more effectively,” they said.

The letter, signed by over 30 health organisations, called for action on health that “integrates the action of Member States and helps them to address the unprecedented challenges we are facing.” 

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