Medical Translation Insight

The Saudi Food & Drug Authority (SFDA) is still relatively young - it was only established in 2003. That's not stopping the newish agency from embracing eCTD though.

SFDA published some information regarding their roadmap towards electronic submission. The timeline looks like this:

• Starting from December 20, 2011, NeeS submissions for human medicinal product dossiers will be accepted by the SFDA according to the Guidance for Submission [PDF link] which has been released in version 3 in December 2011.
• As of September 01, 2012, the NeeS format will be the mandatory submission format for the SFDA. No other formats will be accepted.
• Starting on January 05, 2013, the eCTD will be accepted, which will become the preferred submission format one year later (starting on January 04, 2014).
• Finally, starting from January 03, 2015, only eCTD will be accepted.

The above information is adapted from Exalon and SFDA's web site.

You might also be interested in the following articles:

• What happened to the "global" eCTD?
• eCTD translation
• Working with numbers in Arabic translations

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