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CTD

Common Technical Document

Concept Paper

Describes the perceived problem and the issues to be resolved, and is the trigger of all ICH activities. A Concept Paper for a new harmonisation activity can be submitted by any ICH party or Observer to the Steering Committee

Considerations Document

Are developed by discussion groups i.e., Gene Therapy Discussion Group (GTDG), and ICH & Women Discussion Group. These documents do not undergo the formal step sign-off approval, but do require discussion and endorsement by the Steering Committee