01 October 2011

Health Canada Update: Increased Scope of Submissions being accepted in Electronic Common Technical Document (eCTD) electronic-only filing format

Health Canada is pleased to announce an increase in the types of submissions being accepted in the electronic-only filing format for a subset of eCTD submissions.

The measures outlined in this Notice are effective immediately since they do not impose an obligation but rather provide more options for submission sponsors. Sponsors are encouraged to compile submissions using the most recent Guidance Documents and Notices.

This Notice is meant to be read in conjunction with the Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document (eCTD) Format. The guidance will be changed to reflect this Notice at a future date.

It is Health Canada's intention to continue to broaden the eCTD electronic-only scope and future plans include those submissions currently filed in the eCTD hybrid filing format.

To find more information please use the below mentioned weblink

Health Canada Update: Increased Scope of Submissions being accepted in Electronic Common Technical Document (eCTD) electronic-only filing format

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