##  [Saudi FDA Issues Final Guideline on Economic Evaluation Studies (EES) for Medicinal Products](/mandate/saudi-fda-issues-final-guideline-on-economic-evaluation-studies-ees-for-medicinal-products) 

October 21, 2025

The **Saudi Food and Drug Authority (SFDA)** has released the **final version of the “Economic Evaluations Studies Guideline (INS40043)”**, establishing a comprehensive framework for the conduct, submission, and review of **Economic Evaluation Studies (EES)** for **pharmaceutical (medicinal) products** in Saudi Arabia.

The guideline aims to ensure that drug pricing and reimbursement decisions are supported by **robust pharmacoeconomic evidence**, focusing on cost-effectiveness, safety, and clinical value.

**Key Highlights:**

- Defines the **types of economic evaluations** accepted — Cost-Effectiveness (CEA), Cost-Utility (CUA), Cost-Benefit (CBA), and Cost-Minimization (CMA).
- **Mandatory** for innovative and biological products; **optional** for generics and biosimilars.
- **Exemptions** include OTCs, generics, and biosimilars with registered alternatives.
- Studies must adopt a **healthcare payer perspective**, using **Saudi-specific cost and epidemiological data**.
- Cost-effectiveness thresholds estimated between **SAR 50,000–75,000 per QALY**.
- Requires submission of **epidemiological data, market plan, HTA evidence,** and **pharmacoeconomic forms**.

This final version updates the earlier draft (July 2025) with clarified exemption criteria, minor editorial changes, and submission timelines.



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Source

[https://www.sfda.gov.sa/sites/default/files/2025-10/EconomicEvaluationStudies\_1…](https://www.sfda.gov.sa/sites/default/files/2025-10/EconomicEvaluationStudies_1.pdf)

 

 

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