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Big In Japan: Assessing Seven Years Of Sakigake

11 Global-First Approvals

 
• By Lisa Takagi

Japan’s fast-track approval system for innovative drug candidates has marked its seventh year since launch, during which it has accepted 27 candidates with 13 of these moving to approval. But in recent years the system has faced a decreasing number of admitted candidates, this original infographic analysis shows.

Japan's SAKIGAKE System facing challenging time
13 Products Approved Under Japan's Sakigake Scheme Since Launch • Source: Shutterstock

Since Japan introduced its "Sakigake" pioneering therapy review and approval scheme on a pilot basis in 2015, a total of 27 products have been admitted, with 11 moving through to their first approval globally, including several innovative new treatments for oncology and rare diseases.

However, the system has seen a decreasing number of candidates over its five rounds ending in 2020 before it officially became a permanent system under the country’s Ministry of Health, Labour and Welfare (MHLW),

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