Market Overview

Priority Review System for Drugs and Medical Devices in Japan

  There are various priority review systems to provide the necessary useful new drugs and medical devices to the market as quickly as possible. Following the US FDA's first track system, Japan’s first general priority review system was established in the 1990s. Since then, various new priority review systems, summarized below, have been established and applied.

1. Orphan drug priority review system
2. SAKIGAKE (Pioneer) Review Designation System
3. Conditional Early Approval System
4. Conditional and Time-limited Approval System for regenerative medicines
5. The general priority review system



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