US, EU, Japan Partner in Antimicrobial Resistance Antibiotics

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-13-2017 15:13


The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the US Food and Drug Administration (FDA) have agreed to align their data requirements for certain aspects of the clinical development of new antibiotics in order to stimulate the development of new treatments to fight antimicrobial resistance in antibiotics.

Representatives from the three regulatory agencies met in Vienna in April 2017 and discussed 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. The tripartite meeting in Vienna followed an initial meeting that took place at the EMA in September 2016 where the agencies discussed regulatory approaches for the evaluation of new antibacterial agents.

The 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 the EMA’s approach and the European Commission's priorities to fight antimicrobial resistance.

Source: European Medicines Agency


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