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Introduction

The Ministry of Health (MOH) of Saudi Arabia is the primary government body overseeing the Kingdom’s healthcare system. While the Saudi Food and Drug Authority (SFDA) regulates the quality, safety, and efficacy of medicinal products, the MOH is responsible for health policy, service delivery, and ensuring equitable access to medicines across the country. Together, these entities play a critical role in supporting the Kingdom’s Vision 2030 Health Sector Transformation Program, which seeks to create a sustainable, patient-centric, and digitally advanced healthcare ecosystem.

MOH: Core Responsibilities

The MOH acts as the backbone of healthcare governance in Saudi Arabia. Its functions extend beyond hospital management into areas that directly affect medicinal products:

  1. Policy & Strategic Planning
    • Develops national health strategies to improve population health outcomes.
    • Sets long-term policy frameworks for pharmaceutical availability, affordability, and rational use.
  2. Healthcare Service Delivery
    • Operates and supervises the largest share of government hospitals and primary healthcare centers in the Kingdom.
    • Implements treatment protocols that rely on approved essential medicines and therapeutic guidelines.
  3. Formulary and Essential Medicines
    • Works with the National Unified Procurement Company (NUPCO) and SFDA to establish the national formulary and Essential Medicines List (EML).
    • Ensures that all government hospitals procure medicines aligned with these standardized formularies.
  4. Public Health & Preventive Medicine
    • Manages vaccination campaigns, chronic disease programs, and infectious disease control.
    • Oversees access to antibiotics, antivirals, and vaccines, often coordinating directly with pharmaceutical suppliers.
  5. Digital Transformation & Data
    • Leads initiatives like Seha Virtual Hospital and eHealth platforms to expand access to medicines through telemedicine and e-prescriptions.
    • Supports integration of pharmaceutical data systems to track utilization and outcomes.

MOH and Its Role in Medicinal Products

While the SFDA approves medicinal products for quality and safety, the MOH ensures these products are:

  • Accessible – Distributed across public health facilities nationwide.
  • Affordable – Procured through centralized tenders with NUPCO to control costs.
  • Appropriate – Included in treatment protocols that align with Saudi clinical practice guidelines.
  • Sustainable – Integrated into long-term healthcare financing and reimbursement models.

For pharmaceutical companies, engagement with MOH is essential to ensure that products are not only registered with SFDA but also adopted into the national healthcare delivery system.

Collaboration with Other Regulatory Bodies

The MOH works closely with:

  • SFDA – For Regulatory approval of drugs and medical devices.
  • NUPCO – For centralized procurement and supply chain management.
  • Council of Cooperative Health Insurance (CCHI) – For private sector insurance coverage of medicines.
  • Vision 2030 Health Sector Transformation Program – For advancing privatization, efficiency, and digital healthcare integration.

Why MOH Matters for Pharmaceutical Companies

For pharmaceutical manufacturers and marketing authorization holders (MAHs):

  • Market Access depends on MOH’s adoption of medicines into government hospital formularies.
  • Reimbursement and Procurement are linked to MOH-NUPCO negotiations and pricing strategies.
  • Public Health Impact is defined by MOH-led vaccination drives and chronic disease management programs, creating opportunities for vaccines, biologics, and specialty drugs.

Conclusion

The Saudi Ministry of Health (MOH) plays a pivotal role in shaping the availability, accessibility, and affordability of medicinal products in the Kingdom. While the SFDA ensures Regulatory compliance, the MOH ensures that approved medicines reach the population effectively through its vast healthcare delivery network. For pharmaceutical companies, successful entry into Saudi Arabia requires not just Regulatory approval from SFDA, but also strategic alignment with MOH’s health priorities and procurement systems.

Are you looking to navigate both SFDA approvals and MOH market access for your medicinal products in Saudi Arabia?
Partner with Freyr’s Regulatory experts to streamline submissions, ensure compliance, and maximize market entry success. Contact us today.