Multi-regional clinical trials WG

About this WG

Promotion of global clinical trials including Japan is one of the key factors toward timely access of patients to new drugs.

In this WG, points to consider in conducting the global clinical trials more smoothly and appropriately will be discussed. Especially, global clinical trials in East Asia are one of the main topic for discussion.

What we did

• Guidance
  Based on the discussion in this WG, we assisted MHLW to prepare the relevant notifications. English version is available from below.

Established

August, 2011

Members

Office of New Drug I to V
Office of Cellular and Tissue-based Products
Office of Vaccines and Blood Products
Office of Regulatory Science Coordination

Related information

• Basic principles for conducting phase 1 studies in Japanese prior to initiating multi-regional clinical trials including Japan for drugs in which early clinical development is preceding outside Japan[244KB]

(PSB/PED Notification No. 1225-2, dated December 25, 2023)

• Q&A for basic principles for conducting phase 1 studies in Japanese prior to initiating multi-regional clinical trials including Japan for drugs in which early clinical development is preceding outside Japan[119KB]

(PSB/PED Administrative Notice, dated December 25, 2023)

• Amendment to "Basic Principles on Global Clinical Trials (Reference Cases)”[172KB]

(PSEHB/PED Administrative Notice, dated December 10, 2021)

• Basic Principles for Conducting Phase I Trials in the Japanese Population Prior to Global Clinical Trials[44.1KB]

(PFSB/ELD Administrative Notice, dated October 27, 2014)

• Basic Principles on Global Clinical Trials (Reference Cases)[90.4KB]

(PFSB/ELD Administrative Notice, dated September 5, 2012)

• Basic Principles on Global Clinical Trials[184KB]

(PFSB/ELD Notification No. 0928010, dated September 28, 2007)