Module 1 2021

28/06/2021

PMDA Consultation Timelines

Consultation Request sent to PMDA

Submit F2F

Submit Briefing Document

Response within 5 w. days

Response within 5 w. days

Present. material

-2 M

-5 W -4 W

-3 W

-10D

F2F

-2 D

PMDA confirms date

Receive PMDA queries

PMDA Preliminary Opinion

Distribution to third parties is not allowed

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Consultation Data Package

Example Clinical Trial: - Problems of current therapeutics of the target disease and expected merit of the investigational drug - Package insert - Development History - Planned complete clinical data package - Latest IB - Draft protocol - Clinical trials (tabulated), Toxicity studies (tabulated), References, - Latest Periodic Safety Update Report (PSUR), if any Distribution to third parties is not allowed

28

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