EMA, PMDA and FDA align data requirements and agree on areas of convergence
The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States’ Food and Drug Administration (FDA) have agreed to take steps aimed at supporting the development of new treatments to fight antimicrobial resistance.
The EMA, PMDA, and FDA propose to harmonise some clinical data requirements for new antibiotics. Representatives from the three regulatory agencies have identified a number of areas for which data requirements could be rationalised. These include the design of clinical trials that test new treatments for certain types of bacterial infections, including infections caused by multi-drug resistant organisms.
The agencies are working to update their respective guidance documents respectively. In the meantime, they have said that they will now provide advice to companies consistent with the agreements reached.
Initiating and supporting the development of new antibiotics, in particular those that target multi drug-resistant pathogens, is one of the three pillars in the EU’s approach and European Commission priorities to fighting antimicrobial resistance.
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