22 March 2012

Mission3 News Letter: Saudi Food and Drug Authority (SFDA)- Moving Towards The Acceptance of Electronic Submissions - By Shakul Hameed, Founder, eCTD Regulatory Submission Network

An electronic Submission (or eSubmission) is a set of registration files submitted in electronic format to Health Authorities. The main reasons for submitting electronically are to improve the submission review process, increase accuracy of the submission, and decrease the total costs.

The Saudi Food and Drug Authority (SFDA) recently released a Guidance for Submission (Version 3.0) and a Module 1 eCTD Specification guidance Version 1.0 for GCC (Gulf Cooperation Council). In both guidance documents, SFDA discusses their electronic submission requirements and their plans to implement the eSubmission standards on a step-by-step basis.

SFDA started to accept the NeeS (Non-eCTD electronic submission) format for human medicine submissions, and they are planning to make it mandatory starting from September 1, 2012.  This is an interim step as SFDA moves towards mandating only eCTD Submissions.

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