Module 1 2021

28/06/2021

Early Conditional Approval

Standard regulatory review process

ADR reports Post-marketing surveillance

Exploratory clinical trials

Confirmatory clinical trials

Application Review

Conditional Early Approval System

ADR reports Post-marketing surveillance

Exploratory clinical trials

Application Review

PMDA Nov 2018

Distribution to third parties is not allowed

45

Presentation Outline

Introduction to Japanese Market

PMDA Scientific Advice

Clinical Trials in Japan vs Europe

Recent Updates & Regulatory Pathways

Cultural Considerations

Distribution to third parties is not allowed

46

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