Achievements and challenges of the Sakigake designation system in Japan

Br J Clin Pharmacol

10 March 2021 - The Sakigake designation system (the Sakigake) has been launched to encourage the pioneered development of innovative new medical products for the effective treatment of severe illness in Japan, which allows leveraging the several advantages in prioritised consultation, rapid review, premium drug pricing, and extended data‐protection period. 

The investigators retrospectively analysed the Sakigake products including drugs and regenerative medical products to clarify the achievements and the future issues in this system.

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Michael Wonder

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Michael Wonder

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Medicine , Regulation , Japan