Saudi SFDA publishes roadmap to eCTD, GCC releases Module 1 specification

The Saudi Food & Drug Authority (SFDA) published some further information regarding their road map towards electronic submission implementation:

1. Starting from December 20, 2011, NeeS submissions for human medicinal product dossiers will be accepted by the SFDA according to the "Guidance for Submission" which has been released in version 3 in December last year. Please note that a hard copy of Module 1 is still required at the moment. Details are contained in the afore-mentioned guidance.
2. As from September 01, 2012, the NeeS format will be the mandatory submission format for the SFDA. No other formats will be accepted.
3. Starting from January 05, 2013 the eCTD will be accepted, which will become the preferred submission format one year later (starting January 04, 2014). 
4. Finally, starting from January 03, 2015 only eCTD will be accepted.

A detailed Module 1 specification for submissions in the GCC (Gulf Cooperation Council) has been published in December last year. The GCC Module 1 resembles to a large extend the current EU Module 1.4.1 with regard to structure and metadata requirements. GCC specific documentation requirements are mostly addressed in sections 1.7 Certificates and Documents and 1.8 Pricing. 

The SFDA Drug Sector will conduct workshops to assist pharmaceutical companies and applicants in following the new electronic submission requirements. More information can be obtained through the SFDA website www.sfda.gov.sa or by sending an e-mail to sdr.drug@sfda.gov.sa

[Source: SFDA website]

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