Module 1 2021

28/06/2021

Basic Principles of Global Clinical Trials in Japan

Japan Global Development Guidelines:

Basic Principles on Global Clinical Trials http://www.pmda.go.jp/operations/notice/2007/file/0928010- e.pdf

Basic Principles on Global Clinical Trials (references cases) http://www.pmda.go.jp/kijunsakusei/file/guideline/new_drug/GCT -jirei_en.pdf Basic Principles about Implementation of Phase I Study for Japanese before Participating into Global Clinical Trial. Released on 27 th Oct 2014 https://www.pmda.go.jp/files/000157777.pdf

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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

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