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Datafarm Responds to Health Canada's Announcement of Hybrid eCTD Submission Procedural Simplification
Date:11/9/2009

cent announcement by Health Canada will not only benefit directorates reviewers, but will also provide sponsors real time access to their regulatory filing information and a clear picture of their products’ regulatory lifecycle. Datafarm’s breadth of experience uniquely positions us to assist sponsor companies in their transition to Hybrid eCTD submissions,” concluded Dan.

A Hybrid eCTD as defined by Health Canada denotes that a sponsor company may file an eCTD submission and provide hardcopy for only Modules 1 and 2. This reduces paper volumes required for submission, potentially by hundreds of volumes. Prior to last week’s announcement from Health Canada, a sponsor company would need to notify the agency of their intention to file a Hybrid eCTD. The agency could elect to deny the request. Effective immediately, Health Canada will accept Hybrid eCTD submissions with no prior permission request.

About Datafarm Inc.
Established in 1997, Datafarm is a world leader in high performance electronic regulatory submission solutions for the life sciences industry. Datafarm’s open, modular technologies and professional services experts enable life sciences companies to meet the strict standards of regulatory authorities across the world, helping them achieve quality, accuracy, and compliance to efficiently deliver regulatory reports and submissions. Headquartered in Marlborough, MA, Datafarm has offices in the US, UK, France, and India. For more information, visit www.datafarminc.com.
Datafarm is a registered trademark of Datafarm Inc. All other product and company names mentioned herein are trademarks of their respective holders.

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