Regulators in EU, Japan and US Take Steps to Facilitate Development of New Antibiotics

A press release launched today by the European Medicines Agency (EMA) states their, Japan and US’ intention to facilitate the development of new antibiotics.

Following their meeting in Vienna in April, the EMA, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States’ Food and Drug Administration (FDA) agreed to align data requirements for clinical trials and encourage the development of new antibiotics.

EMA, PMDA and FDA representatives discussed trial design targeting also multi-drug bacterial infections and identified the areas where data requirements in the three regions could align. The regulatory agencies will work to update their guidance documents and in the meatime advise individual medicine developers.

Source: European Medicines Agency

Read the full press release & more details here.