Mastering SFDA Economic Evaluation Studies (EES): Navigating Forms A, B, and C (Pharmaceuticals)

(Pharmaceuticals) As of July 2025, adherence to the SFDA's Economic Evaluation Studies (EES) guidelines is mandatory for initial registration, price re-evaluation, and renewal of all human pharmaceutical products. This operational program dissects the granular requirements of the EES submission dossier to eliminate the risk of rejection and market exclusion. Participants are guided through Form A, covering local epidemiological data, five-year market-share projections, and documentation of patient access agreements. They then advance to the economic modeling required for Form B, including cost-effectiveness and cost-utility analyses constructed from a localized payer perspective. The curriculum emphasizes the SFDA requirement that direct healthcare costs be reported in Saudi Riyals and that comparators reflect the prevailing Saudi standard of practice. Finally, participants learn to summarize partial economic studies to satisfy the Budget Impact Analysis requirements of Form C. Because non-compliance results in regulatory rejection, the program equips HEOR and pricing teams with the practical skills to localize global value dossiers into fully compliant Saudi submissions.