ICH Electronic Common Technical Document Specification (eCTD) V 3.2.2

Document Resource: ICH Electronic Common Technical Document Specification (eCTD) V 3.2.2

Description:

The ICH M4 Expert Working Group (EWG) has defined the Common Technical Document (CTD). The
ICH M2 EWG has defined, in the current document, the specification for the Electronic Common Technical Document (eCTD). The eCTD is defined as an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation,review, life cycle management and archiving of the electronic submission. The eCTD specification lists the
criteria that will make an electronic submission technically valid. The focus of the specification is to provide the ability to transfer the registration application electronically from industry to a regulatory
authority. Industry to industry and agency to agency transfer is not addressed.

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