Module 5 Presentations

18/07/2024

Development in case of Exceptional Circumstances

MHLW is exploring the possibility to accept ONLY foreign data in exceptional circumstances:

Three conditions are required:

1) Pivotal clinical trials have already been completed overseas

2) Additional clinical trials in Japan not be feasible before domestic filings due to extremely small numbers of patients or other reasons

3) The available efficacy and safety data indicate that benefits would outweigh risks in Japanese

MHLW decides whether a particular drug is eligible for the scheme above or not

Distribution to third parties is not allowed

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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

Basic Principle on Global Clinical trials and waver of Ph.1 studies in Japanese ( NEW 25 Dec 2023 ) https://www.mhlw.go.jp/hourei/doc/tsuchi/T231226I0030.pdf

Q&A for basic principles for conducting/not conducting phase 1 studies ( NEW 25 Dec 2023 ) https://www.mhlw.go.jp/hourei/doc/tsuchi/T231226I0030.pdf

Distribution to third parties is not allowed

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