Module 1 2021

28/06/2021

Clinical Trials: Japan vs Europe

Japan

EU

Clinical Trial Notification Document

Clinical Trial Application Form

Protocol

Scientific Rational for the study

Investigational Brochure

Protocol

Investigational Medicinal Product Document (IMPD)

Informed Consent 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

EU Regulation on Paediatric Medicines 12 Dec 2006

Ethical considerations for clinical trials on medicinal products 2008

In Japan ICH E11 guidance is so far the only document on Paediatric Clinical Trials MHLW - Notification 15 th Dec 2000 - Q&A on ICH E11 22 nd June 2001

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

Distribution to third parties is not allowed

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