Module 1 2021

28/06/2021

Clinical Trials: Japan vs Europe

Parallel Regulatory-EC Approval

Regulatory Approval

EC Approval

Sequential Regulatory-EC Approval

Regulatory Approval

EC Approval

Distribution to third parties is not allowed

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Clinical Trials: Japan vs Europe

EU

Japan

EC on minors and incapacitated adults must have expertise or take advice from expert EC timelines maximum 60 days (30 days in gene therapy, somatic therapy and Genetic Modified Organisms) from date of receipt of a valid application to give its reasoned opinion EC may send a single request for information supplementary to that already replied by applicant

Not clearly specified in GCP Ordinance

No defined timelines. It depends on the sites

there is no limitation to the number of requests

Distribution to third parties is not allowed

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