;   Medical Translation Insight: Saudi Food & Drug Authority publishes roadmap to eCTD - ForeignExchange Translations

Saudi Food & Drug Authority publishes roadmap to eCTDThe 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.

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