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) announced on June 12, 2017 that EMA, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the US FDA were aligning their data requirements for clinical development of new antibiotics. The agencies will also be updating relative guidance documents and providing drug developers with advice.
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: EMA
Shilpa Medicare Launches ‘Hybrid CDMO’ at DCAT Week 2025
March 17th 2025This model is being positioned by Shilpa as a dual approach that offers comprehensive discovery, clinical, and commercial outsourcing services in addition to commercially ready, “off-the-shelf” novel formulations for b2b licensing.
