Comparative Regulatory Requirements and Strategic Pathways for Topical and Nasal Dosage Forms in GCC and MENA Markets

Background: Regulatory expectations for topical and nasal products differ across Gulf Cooperation Council (GCC) and Middle East–North Africa (MENA) markets. Clear understanding of dossier formats, stability, labeling and site requirements is essential for predictable approvals. Objectives: To compare prevailing frameworks and outline practical strategies that shorten review cycles while ensuring compliance for topical and nasal dosage forms. Methods: A structured desk review of primary guidance from GCC-DR, SFDA (Saudi Arabia), MOHAP (UAE), EDA (Egypt), and JFDA (Jordan), alongside WHO/ICH quality references, was synthesized into an actionable comparison. Results: GCC countries show higher alignment via centralized and national eCTD pathways, while MENA markets are heterogeneous in format and evidence expectations (e.g., device performance for nasal sprays). Conclusion: Regionaware sequencing, robust stability justifications (Zone IVB), and early alignment on country-specific documentation materially reduce risk of delay for topical and nasal submissions.