SFDA Announcement – Implementation of eSubmission for human pharmaceuticals

 

SFDA has announced to the pharmaceutical companies about their implementation timeframe for eSubmission.

The SFDA has already started to accepting the Non-eCTD electronic Submissions (NeeS) format starting from 20^th December 2011. For more information about NeeS submission and requirements for preparing NeeS submission please refer the “SFDA Guidance for Submission (V 3.0)” document.

SFDA has mentioned the NeeS Submission format will be mandatory format starting from 1^st September 2012.  

An eCTD format will accept starting from 5^th January 2013. An eCTD is the preferable format for SFDA human pharmaceuticals regulatory submissions from 4^th January 2014. SFDA has plan to accept only eCTD Submissions starting from 03Jan2015.

Kindly note that the SFDA pharmaceutical sector will hold a number of workshops to helpcompanies meet these technical regulatory requirements for more information about the workshops will get update soon.

If company has any questions about the SFDA eSubmission (or) implementation can contact SFDA through mail.

The English version of this implementation guidance will updated by SFDA soon.

Source: http://www.sfda.gov.sa/PDF/Ar/%7BF89099F1-167D-4914-97A0-9225EA33D87F%7D.pdf