EMA suggests restructuring eCTD to facilitate public access to documents

This article was originally published in SRA

04 Jul 2011
News

Vibha Sharma @ScripRegVibha vibha.sharma@informa.com

Executive Summary

The European Medicines Agency wants drug regulatory authorities around the world to work towards restructuring the current eCTD (electronic common technical document) submission format to better enable redacting of commercially confidential information from these submissions so that they can be made available to the public¹.

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EMA suggests restructuring eCTD to facilitate public access to documents

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