Module 5 Presentations

18/07/2024

CTN Requirements: Japan vs Europe

Japan

EU

Clinical Trial Notification Document

ClinicalTrial Application Form

Protocol

Scientific Rational for the study

Investigational Brochure

Protocol

Investigational Medicinal Product Document (IMPD)

InformedConsent Form (ICF)

CRF (Case Report Form)

Manufacturer’s authorisation or Importer’s authorisation plus QP declaration on GMP for each manufacturing site.

Investigational Brochure (IB)

Distribution to third parties is not allowed

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Paediatric Clinical Trials

In contrast to EU/US, in Japan clinical development in the paediatric population is not mandatory

New incentives for paediatric indications recently introduced

- Pricing premium - Additional market exclusivity period

Distribution to third parties is not allowed

36

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