Pmda - Pharmaceuticals and Medical Devices Agency

Regulatory Science/The Science Board/Standard Development

Global Clinical Study 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.


August, 2011


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

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

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

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

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

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

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