Regulators from Europe, the United States and Japan have agreed to pool their data requirements with the aim of facilitating clinical developments of new antibiotics.
This alignment is intended to stimulate the development of new treatments to fight the growing threat of antimicrobial resistance.
Representatives from the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) recently met to discuss the recommendations for the design of clinical trials that test new treatments for certain types of bacterial infections, including infections caused by multi-drug resistant organisms.
They identified a number of areas where the data requirements in the three regions could be streamlined.
EMA, PMDA, and FDA will be working to update their guidance documents respectively. While the updates are ongoing, they will provide advice to individual medicine developers in line with the agreements reached.
Stimulating and facilitating the development of new antibiotics, in particular those targeting multidrug-resistant pathogens, is one of the three pillars in EMA’s approach and European Commission’s priorities to fight antimicrobial resistance.
Responsible use of existing antibiotics both in humans and animals to limit the development of resistance and preserve the efficacy of medicines for future generations, and the collection of robust data on antibiotic consumption, in particular in animals, to inform antimicrobial policies are the other two pillars.