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Established in 2003, the Saudi Food and Drug Authority (SFDA) is the primary Regulatory body overseeing the quality, safety, and efficacy of medicinal products in the Kingdom of Saudi Arabia. Operating as an independent authority, it plays a pivotal role in aligning national healthcare outcomes with global standards, including ICH, WHO, and PIC/S frameworks. With digital platforms, robust pharmacovigilance, and stringent review systems, SFDA ensures medicinal products meet both scientific rigor and public health needs.

Here are 10 key insights into SFDA’s evolving Regulatory landscape for medicinal products:

1. WHO Maturity Level 4: Globally Recognized Regulatory Authority

In 2022, SFDA achieved WHO Global Benchmarking Maturity Level 4—one of only a few authorities worldwide. This means it meets advanced Regulatory system criteria in marketing authorization, GMP/GVP inspections, and post-market surveillance for pharmaceuticals and vaccines.

2. Preclinical Requirements Now Mandatory for New Drugs

SFDA mandates submission of pharmacological and toxicological data for New Chemical Entities (NCEs). These must align with ICH M3 and SFDA’s own preclinical guidance issued in 2024, ensuring animal studies, genotoxicity, and safety margins are well justified.

3. Structured Submissions via eCTD Format

Marketing Authorization Applications must be in electronic Common Technical Document (eCTD) format, with Module 1 tailored to KSA-specific regulatory and labeling needs.

  • Lifecycle operations (variations, renewals) must follow defined eCTD sequences.

4. Orphan Drug Designation & Braille Labeling Compliance

Medicines for rare diseases can follow SFDA’s abbreviated review process, including possible fee waivers. Braille labels are compulsory under KSA guidelines to ensure access and patient safety.

5. GMP Enforcement for Local and Global Manufacturers

SFDA performs GMP inspections in the Kingdom of Saudi Arabia and abroad. Facilities must be pre-approved and listed in the company’s dossier. Any variation to manufacturing processes (CMC changes, tech transfer) must be declared using SFDA’s variation templates.

6. Advanced Pharmacovigilance & Risk-Based Post-Market Surveillance

  • SFDA requires Risk Management Plans (RMPs) for all innovative drugs.
  • Continuous monitoring of pregnancy outcomes, pediatric safety, and pharmacogenomics is required.
  • Product Information must be updated with class-effect warnings or global signal changes.

7. Pathway for Advanced Therapies & Biologics

Biologics, biosimilars, gene therapies, and cell-based treatments are reviewed under a specialized biologics division. SFDA aligns with WHO and ICH Q5-Q6 series for comparability, stability, and safety.

8. Regulated Companion Diagnostics (CDx) Integration

As of 2025, SFDA requires co-approval of companion diagnostics for targeted therapies (e.g., oncology drugs). CDx devices must undergo Class C medical device registration alongside the drug submission.

9. Defined Review Timelines for Faster Access

Standard review period for MAAs is 210 calendar days, with accelerated review options for orphan drugs or priority products.

  • Fast track review = ~90 days
  • Variation approvals = 30–60 days

10. Fully Digital Submission via GHAD System

The GHAD e-platform is mandatory for submission, status tracking, and lifecycle operations. Companies must be pre-registered and authorized to submit on behalf of global manufacturers.

 Final Thoughts

SFDA continues to evolve as a globally recognized, harmonized regulator. Its technically advanced frameworks—from preclinical evaluation to post-marketing pharmacovigilance—enable robust, end-to-end oversight of medicinal products. With platforms like GHAD advancing and stronger alignment with ICH guidelines, manufacturers can expect a Regulatory environment that is both scientifically rigorous and increasingly transparent.

If you're preparing for product registration in the Kingdom of Saudi Arabia or navigating complex post-approval requirements, our regulatory experts are here to support you every step of the way.

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