✅ 1. Why eCTD Is Mandatory in the GCC Region
In the Gulf Cooperation Council (GCC) region (including Saudi Arabia, UAE, Kuwait, Oman, Bahrain, Qatar), regulatory authorities have adopted the electronic Common Technical Document (eCTD) standard to unify and modernize how pharmaceutical dossiers are submitted.
This aligns with global regulatory expectations to facilitate efficient review, lifecycle management, and harmonized data structure.
Many GCC jurisdictions have either implemented or are moving toward mandatory eCTD submission for marketing authorization applications (MAAs), with timelines set by each health authority — e.g., Qatar made eCTD mandatory from September 2020, and other states followed similar timetables.
The main reasons eCTD is mandatory:
✔ Standardized format across applications (quality, safety, efficacy)
✔ Easier life-cycle management (updates, variations, responses)
✔ Faster electronic review and tracking
✔ Compliance with international harmonized standards (ICH eCTD)