Harmonizing eCTD Submission Content

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Today’s entry was provided by Drug Information Expert S. Albert Edwards, Pharm.D.

Part of the promise of the ICH at its inception in the early 90’s was a common dossier, or application structure, for all regions.  However, 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.

Where might we start in reversing this?  The US and Canada are geographic neighbors; the FDA and HPB often meet, trade regulatory information and confer.  Might they consider a common Module 1?  If agreement could be reached on this Module, could we use the learned success to stimulate other regions to consider other submission harmonization efforts?

Based on the large number of submissions destined for the US and Canada in a year, how much time could we save and how much more efficiently could our systems and people be if there was a harmonized Module 1 for the US and Canada?

Author: GuestPost

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