CTD / eCTD

Common Technical Document

CTD
The compilation (including content and format) of the Application Dossiers for marketing authorization follows the structure and format of the Common Technical Document as agreed in November 2000 within the International Conference on Harmonization (ICH) framework. It is mandatory from July 1, 2003. The administrative part has to be provided in Japanese, along with additional data specific for Japanese regulatory requirements.

Resources:

On July 1, 2001 the Japanese Ministry of Health, Labor and Welfare introduced on voluntarily and experimental basis  the acceptance of the submissions for new product approvals of Japan.
A full up-to-date description of the Japanese CTD/eCTD is available in the JKS Document Store, along with other relevant documents.

 

Japanese CTD/eCTD Basics Reports: 4_D_M001

This is a JKS milestone document - describing a Dossier phase of the lifecycle of the regulated medicinal products in Japan. Full up-to-date description of the basics of the CTD/eCTD as implemented in Japan with references and annotations. 28-page Drugs Lifecycle document.