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