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FDAnews Drug Daily Bulletin
June 5, 2012 | Vol. 9 No. 110
Saudi Arabia Rolls Out Timeline for Transition to eCTD by 2015
Beginning Sept. 1, new drug applications to the Saudi Food and Drug Administration (SFDA) must include an electronically submitted non-electronic common technical document (CTD). The non-eCTD electronic submission, or NeeS, format will be allowed on an interim basis until Jan. 3, 2015, when the SFDA will accept only electronic CTDs. The transition from electronic submission of the NeeS format to eCTD format also includes two interim periods — Jan. 5, 2013, after which either format will be accepted, and Jan. 4, 2014, when NeeS will be accepted but eCTD is preferred.
International Pharmaceutical Regulatory Monitor
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