EMA Publishes Draft Guidance on Antibiotic Development

January 14, 2019

The revised guidance aims to strengthen the agency’s global approach to develop new antibacterial medicines.

The European Medicines Agency (EMA) has published the third revision of its guideline on the evaluation of human medicines for the treatment of bacterial infections for a six-month public consultation. 

The agency reports that the revised guidance reflects the outcome of discussions among regulators in the European Union (EU), the United States, and Japan over the last few years on how to align their respective data requirements so that medicine developers can design clinical trials that meet the evidence needs of multiple regulatory agencies. 

In addition, the guidance, adopted by EMA’s human medicines committee, offers clarification on the clinical development of antibacterial agents that are expected to address an unmet medical need in accordance with experience gained from previous regulatory decisions. Specific advice has also been added with regards to the EU regulatory requirements to develop medicines for the treatment of uncomplicated urinary tract infections and gonorrhea.

Comments should be submitted by July 31, 2019 to idwpecretariat@ema.europa.eu.

Source: EMA