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Japan Takes New Steps To Build On Real-World Data Foundations

PMDA Shares Views On Revised Law

 
• By Lisa Takagi

As Japan widens its window for the use of real-world data to support drug development though revision of the Next Generation Medical Infrastructure Act, the pharma industry is hoping for more regular inclusion in regulatory filings. A dedicated group within the PMDA shares its views on how the area is developing and practical measures being taken to drive RWD adoption.

Japan's revised Next Generation Medical Infrastructure Act is expected to take effect by May 2024
Japan's revised Next Generation Medical Infrastructure Act expected to take effect by May 2024 • Source: Shutterstock

Japan is set to widen the use of digital information, including real-world data (RWD), through the revision of its Next Generation Medical Infrastructure Act.

The revised legislation, announced in May, is expected to come into effect within a year and should open the window for broader use of RWD in the country, particularly for...

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