New Regulations Expected to Accelerate Drug Development in Japan

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Changes in Japan's Regulatory Approach Facilitate Entry for Overseas Emerging Biopharma Companies

Takuya Higuchi and Hayato Sawada
Innovative Drug Development Business Unit
Linical H.Q., Japan

In December 2023, the Japanese health authority released their notification about the requirement of a Japanese Phase I study prior to multi-regional clinical trials including Japan. In the present article, we provide an overview of this regulatory reform, which is expected to accelerate drug developments in Japan, and future prospects.

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