The GCC has crossed a threshold. Locally generated, registry-grade real-world evidence is now required to support marketing authorization, health technology assessment, and formulary access across the region. Extrapolated foreign RWE no longer satisfies the evidentiary bar.

The constraint on GCC RWE submissions is not data availability. Malaffi, Nabidh, Riayati, and the Saudi Cancer Registry hold submission-grade data today. The constraint is registry-governance discipline — the operational architecture that turns those data assets into evidence a regulator will accept.

This paper introduces the GCC Registry Readiness Model — five operational pillars, fifteen success criteria, and five measurable KPIs — derived from a peer-reviewed multi-country RWE program led across Asia-Pacific (2017–2023) and translated for the Gulf’s regulatory, data-infrastructure, and jurisdictional environment.

For regulators and HTA bodies designing evidence-review pathways.
For sponsors and CROs commissioning GCC-native registries.
For SMOs, academic centers, and investigators executing on the ground.