Advanced therapy medicinal products (ATMPs), including cell and gene therapies, offer potentially transformative treatment for serious and rare diseases. Their complexity means that approval is only one part of patient access.
The regulatory picture
GCC authorities are building capacity for advanced therapies. In the UAE, EDE regulates relevant medical and pharmaceutical products, including stem-cell products. In Saudi Arabia, the current SFDA Verification and Abridged Pathways guidance, Version 3.0, explicitly excludes advanced therapy medicinal products. Developers should assess the applicable ATMP route directly against current SFDA requirements rather than assume eligibility for general reliance pathways.
Readiness beyond the dossier
Treatment centre qualification: trained clinical teams and accredited facilities.
Chain of identity and custody: traceability from patient cells to infusion.
Cold-chain logistics: cryogenic transport, import permits and customs procedures.
Long-term follow-up: safety monitoring that can last many years.
Pharmacovigilance: systems adapted to delayed and rare adverse events.
Payment models: high one-time costs may require outcomes-based or instalment agreements.
Patient identification: diagnosis, genetic testing and referral pathways.
Regional relevance
Inherited blood disorders and other genetic conditions are an important health priority in parts of the Gulf and Arab region, which makes readiness for advanced therapies especially relevant.
How HERMS supports
HERMS supports advanced-therapy developers with regulatory strategy, pathway assessment, pharmacovigilance planning, treatment-centre readiness and market access design for the GCC.
Planning an advanced therapy launch in the Gulf? Speak to HERMS about a readiness assessment. Contact HERMS →
References
EDE – About Us: https://www.ede.gov.ae/en/home
SFDA – Verification and Abridged Pathways, Version 3.0 (scope exclusions): https://www.sfda.gov.sa/sites/default/files/2026-04/VerificationAbridgedPathways3.pdf