Japan's Ministry of Health, Labor and Welfare (MHLW) wants companies to offer innovative drug candidates for its accelerated approval "sakigake" designation system to be launched this fiscal year with a focus on shortened review times.
The accelerated review was announced last week by MHLW's Pharmaceutical Affairs and Food Sanitation Council.
Any products considered must display a novel mechanism of action, be scalable commercially, show high efficacy and be developed and planned for approval in Japan ahead of the rest of the world.
Designation means prior reviews by the Pharmaceuticals and Medical Devices Agency (PMDA) before the launch of Phase III clinical studies. The time between Phase III document submissions and clinical trial consultations will be reduced from two months to one month, and the review period from 12 months to six months.
Separately, the PMDA has also started consultation services to academic institutions on protocols for their Phase IIb or later confirmatory studies, aiming at products with great unmet medical needs.