Module 1 2021

25/06/2021

Electronic submissions: Region by region – Other Regions (2)

• Australia

• The TGA have joined the ICH eCTD EWG to support their eCTD implementation project • The TGA ran a pilot and from 2015 started accepting all marketing submission types for prescription, biological and registered non-prescription medicines in eCTD format • Exception: Medical Devices, New API and Excipients • Nov 2021: TGA will begin staged transition to eCTD-only for all prescription medicines. • Saudi Arabia and the Gulf States

• The SFDA has accepted the eCTD since 2013 and made it mandatory in 2016

• Not without issues (e.g. the need for baselines for all products)

• Additional adoption in Gulf States: •

United Arab Emirates (on October 1st, 2017) • Oman (on January 1st, 2015) • Bahrain (on November 1st, 2016) • Qatar (optional as of September 1st, 2019, and mandatory starting September 1st, 2020) • Jordan (on 1st January 1st, 2019, with a pilot phase between the January 1st, 2019, and the March 1st, 2019) • Saudi Arabia and Gulf Cooperation Council (GCC) countries follow the GCC eCTD specifications that are common for the region including a specific Module 1.

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• South Africa • The MCC went live with the eCTD for NCE submissions on 1 st Apr 2016 and for generics from 2 nd Jan 2017 • Thailand • The Thai FDA ran an eCTD pilot in 2014 and implemented in 2015 • Began Transitioning to eCTD only in 2017 • Turkey • Turkey have talked in the past about a NeeS for eCTD, but using folders named in Turkish • This naming convention would make all the links in all of the files we created for the eCTD invalid • In Feb 2017 the agency announced a new project for eCTD Electronic submissions: Region by region – Other Regions (3)

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