Gulf Cooperation Council (GCC)

Neither SFDA (Saudi) nor the GCC framework has announced adoption of eCTD v4.0. The GCC's current eCTD framework is built on the ICH eCTD specification 3.2.2, with the regional Module 1 governed by the GCC Module 1 Specification v1.5. Watch SFDA's website for any future v4.0 roadmap; member states share the same regional Module 1 standard.

Do not expect a v4.0 switch plan for the GCC yet. The current baseline to master is ICH eCTD 3.2.2 with the GCC Module 1 Specification v1.5 (the regional Module 1 standard published by Saudi SFDA). Build submissions against that, not v4.0.

The GCC's current eCTD framework is based on the ICH eCTD specification 3.2.2; the regional Module 1 is uniformly governed by the GCC Module 1 Specification v1.5, published by Saudi SFDA and shared by all GCC member states. For human medicines, eCTD is mandated across GCC members (Saudi is the lead and earliest adopter); each member runs its own regulator and submission portal (e.g. Saudi via GHAD / eSDR) yet shares the same regional Module 1 standard. Modules 2–5 follow the ICH eCTD 3.2.2 specification.

The GCC Module 1 Specification v1.5 is the current official regional Module 1 standard for the GCC (published by Saudi SFDA). v1.5 introduced the "Submission Unit" concept to refine sub-actions within a regulatory activity, and removed health / herbal / veterinary submission types while updating checksums and controlled vocabularies. All member states (Saudi Arabia, UAE, Kuwait, Bahrain, Oman, Qatar, Yemen) share this regional Module 1 but submit through their national portals and complete Module 1 per their own national requirements. Build and self-check the regional Module 1 against v1.5.