Harmonizing eCTD Submission Content
Mar17

Harmonizing eCTD Submission Content

As adoption of the Common Technical Document and the eCTD has progressed through the regions, variations in the content and structure of the dossier/application requirements have emerged, making submissions regionally different. This slows the preparation of submission content and delivery, and lobbies against submission efficiency aiding a rapid health product development timeline. Harmonized submission content and structure are lofty goals that often never realistically and unilaterally enter the streamlined equation for product development.

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FDA eCTD Review Process Q&A

Earlier this week, GlobalSubmit and Cato Research held an educational webinar on the FDA eCTD Review Process. The purpose of the webinar was to provide an overview of the various steps and stages that a drug application goes through in order to be approved by the FDA and marketed in the United States. During the webinar, GlobalSubmit’s CTO Jason Rock discussed the FDA’s workflow, the challenges they face in the electronic...

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Progress for Health Canada’s Electronic Review Program

Well,it’s back to business after the holiday break. As promised, here’s my update on what’s happening at Health Canada. At the recent DIA eSubmissions conference, Health Canada’s Vianney Caron presented an update on eCTD at Health Canada. The E-Review Program The purpose of Health Canada’s E-Review program is to support branch business processes throughout the health product life cycle across product lines using an...

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Final Health Canada eCTD Guidance Addresses Naming Conventions, Lifecycle Operations

Health Canada has posted a final version of Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document (eCTD) Format on their web site. This version, dated November 4, 2009, replaces the draft version dated January 25, 2006. On the whole, the changes are more evolutionary than revolutionary. Throughout the document, the previous terminology of “Annual update forms summarizing the Notices of Change”...

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Top 10 Validation Errors for Health Canada

  The AAPS Workshop on Strategic Management of CMC Dossiers in the eCTD Format: What CMC Professionals Need to Know Now! was held March 9-11, 2009. There were some great presentations, and best of all they are publically available. The agenda contains links to the presentations. All the presentations were good but some of the highlights for me appear below. There’s great information on Japan and Health Canada that has been rather...

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