Module 5 Presentations

18/07/2024

MHLW

MHLW (Ministry of Health Labor and Welfare)

 Healthcare Policy

 Enforcement of administrative measures, eg: approval of JNDAs

 Guidelines

 Pricing (Health policy Bureau)

 Safety measures for emergency cases

https://www.mhlw.go.jp/english/

Distribution to third parties is not allowed

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PMDA

PMDA (Pharmaceutical and Medical Device Agency)

 Consultations

 Implementation of work such as review of CTN/JNDA

 Interface with applicants during review

 GCP/GMP Inspections

 Document compliance review

https://www.pmda.go.jp/english/index.html

Distribution to third parties is not allowed

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