Module 5 Presentations

18/07/2024

Clinical Trial Infrastructure

Source: OECD Health 2008, 2009, 2010 Data

- Good quality but Cost is high compared with Europe/US

- Government has just issued a plan to promote the expansion of IRB and curb High cost

Distribution to third parties is not allowed

11

Japanese Regulatory Authorities

MHLW

PMDA

Partner during Clinical trials

Distribution to third parties is not allowed

12

6