EMA Consults on Harmonized Antibacterial Drug Development Guideline

Regulatory NewsRegulatory News | 14 January 2019 |  By 

The European Medicines Agency (EMA) on Monday released a draft version of its guideline on developing antibacterial medicines for consultation.
The 30-page guideline, which is now on its third revision, has been updated to reflect a harmonized approach to antibacterial drug development based on the tripartite discussions between EMA, the US Food and Drug Administration and Japan's Pharmaceuticals and Medical Devices Agency.
"Antimicrobial resistance is a global public health problem. Regulators in the European Union, the United States and Japan have had extensive discussions over the last few years to explore and agree how to align as much as possible their respective data requirements so that medicine developers can design clinical trials that meet the evidence needs of multiple regulatory agencies," EMA writes.
According to EMA, the guideline applies to single agent antibacterial products, antibacterial drugs intended to be used in combination with other products and beta-lactam agents developed for use with beta-lactamase inhibitors.
The agency says that some of principles described in the guideline may also be applied to developing bacteriophages; drugs that affect bacterial virulence; products that inhibit bacterial growth; and monoclonal antibodies (mAbs) that treat or prevent specific infections.
The guideline has also been revised to provide clarification on the clinical development of antibacterial drugs intended to address unmet medical needs.
Additionally, EMA says the guideline has been updated to include EU-specific regulatory requirements for developing drugs to treat uncomplicated urinary tract infections and gonorrhea and now includes recommendations for when single pivotal trials may be accepted for infection-site-specific indications.
EMA has also removed certain portions of the guideline it says are now covered in greater detail elsewhere, including a section on pharmacokinetics and pharmacodynamics and a section on developing drugs to treat pulmonary disease due to Mycobacterium tuberculosis. Recommendations for pediatric drug development was removed as it is being discussed in a separate addendum.
Within the guidance, EMA details its recommendations for nonclinical and clinical development for antibacterial drugs and provides input on conducting safety and efficacy analyses. The guideline also includes recommendations for clinical studies for a number of specific types of infections, including community-acquired pneumonia, complicated intra-abdominal infections and acute bacterial sinusitis.
EMA is asking stakeholders to submit comments on the revised guideline by 31 July 2019.
EMA, Draft Guideline


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