Japan's MHLW lines up about 50 candidates for fast-track 'sakigake' process

A special panel of Japan's Ministry of Health, Labour and Welfare (MHLW) received around 50 formal applications and has cleared screening for the "sakigake" fast-track drug and device review process before the Pharmaceuticals and Medical Devices Agency (PMDA), according to a ministry spokesman.

Japanese Prime Minister Shinzo Abe

The Evaluation and Licensing Division has passed along the 50 from a list of more than 60, the spokesman said, with the candidates slated to be announced in a month. The "sakigake designation system" is aimed at expediting the review of innovative drugs, regenerative medicines and devices developed in Japan earlier than the rest of the world. This includes prioritized consultations and priority review status.

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, PMDA said in April.

Designation means prior reviews 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 6 months.

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.

Separately, in April, PMDA announced plans to accelerate high-quality drug and medical device reviews to 12 months for at least 70% of new drugs filed for approval with domestic firms favored. The target is for the fiscal year starting April 1, and would compare to a 60% target this year and place PMDA on a path to raise the level to 80% for both products by fiscal 2018.

- here are the sakigake guidelines

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