Multi-regional clinical trials WG

In order to promote clinical development in Japan, this WG collects, analyzes and shares cases regarding issues related to Multi-Regional Clinical Trials, and exchanges opinions with pharmaceutical industry.
（Activity period:：From August, 2011）

 

Activities

• Collecting analyzing and sharing cases regarding issues related to Multi-Regional Clinical Trials.
• Exchanging opinions with pharmaceutical industry.
• Cooperation in the preparation of related notifications issued by MHLW.

The activities conducted over the last five years.

Guidance

Based on the discussion in this WG, we assisted MHLW to prepare the relevant notifications.

Related Notification

• Guidance and Guidelines for Multi-Regional Clinical Trials.