EU, U.S. and Japanese regulators join forces on antibiotic trials

Print 16 June 2017
Ben Adams / Fierce Biotech

The three drug regulators from Europe, the U.S. and Japan have come together in a data share program aimed at boosting antibiotic development.

Long held as one of the most overlooked but potentially devastating areas of development, antibiotic resistance and a lack of new meds in this area have increasingly become a major concern for governments.

Now, too, regulators are looking to help stimulate biopharmas in getting new meds in the clinic, something they are typically reluctant to do as they have little to no ROI, especially when compared the industry’s work on oncology and rare diseases.

To this end, the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the Food and Drug Administration (FDA) have, according to a statement, “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 and protect global public health.”

Reps from across all three agencies sat down in a recent meeting in Vienna, Austria, to come up with new plans to help design studies to test new treatments for certain types of bacterial infections, including infections caused by multi-drug resistant organisms.

The results showed a number of areas where data requirements in the three regions “could be streamlined,” according to the EMA.

All three will now be working to update their respective guidance documents. While the updates are ongoing, the agencies added that they will provide advice to individual biopharma companies.

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