
Europe, Japan, and US Align on Antibiotics
The three regulatory agencies have agreed to data requirements for development of new antibiotics.
The European Medicines Agency (EMA)
The alignment follows meetings held in September 2016 and April 2017 where the agencies discussed their approaches to the development and evaluation of antibiotics. The April 2017 meeting specifically discussed the design of clinical trials to test new treatments, particularly those against drug-resistant organisms.
“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,” EMA stated in a press release.
Source:
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.