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Japan Planning To Expand Phase I Waivers

Under Certain Conditions

 
• By Lisa Takagi

The new measure aims to attract more bioventure-oriented products into the Japanese market. The country has been easing requirements for local Phase I trials gradually over the past decade.

The MHLW announced the policy to basically require Japanese Phase I in 2007
MHLW has basically required local Phase I trials since 2007, but eased requirements from 2014 • Source: Shutterstock

Japan is planning to waive a requirement to conduct local Phase I clinical studies for drugs that are already in clinical development outside the country.

The change, which may come into effect in the next couple of months, is aimed primarily at encouraging the Japanese development of novel, high-need, foreign-originated products for serious diseases, especially from

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