---
title: New Regulations Expected to Accelerate Drug Development in Japan
description: Recently, the Japanese health authority released their notification about the requirement of a Japanese Phase 1 study prior to MRCT including Japan.
---

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# [New Regulations Expected to Accelerate Drug Development in Japan](https://www.linical.com/white-papers/new-regulations-expediting-drug-development-in-japan-intro)

 Written by [Ali Cundari](https://www.linical.com/white-papers/author/ali-cundari) | Jan 29, 2024 9:26:57 PM

**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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