In the recent report “New Drug Approvals in ICH Countries 2005-2014”, the Centre for Innovation in Regulatory Science has shown that, in 2014, Japan’s the Pharmaceuticals and Medical Devices Agency was the fastest regulatory agency, with a median approval time of 306 days for new active substances (NASs) compared to medians of 343 and 418 days for the FDA and EMA, respectively. Over the past decade, approval times at FDA and EMA have remained relatively stable, but Japan’s approval times have decreased substantially, e.g., from ~800 days in 2005 and 2006 to 306 days in 2014. A marketing application for brodalumab, which targets IL17 receptor, was recently submitted for review in Japan. Brodalumab is undergoing evaluation as a treatment for plaque psoriasis, psoriatic arthritis, pustular psoriasis, psoriatic erythroderma.
the official website of the antibody society
