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Navigating drug registration and compliance in Saudi Arabia requires a solid understanding of the Saudi Food and Drug Authority’s (SFDA) Regulatory landscape. Whether you're a Regulatory affairs professional, a pharmaceutical company entering the market, or a local marketing authorization holder (MAH), knowing the right questions to ask is half the battle.

Below are the top frequently asked questions (FAQs) that address essential aspects of SFDA drug regulation, compiled from current Regulatory practices and official guidelines.

FAQ 1: What is the SFDA’s role in drug regulation?

The Saudi Food and Drug Authority (SFDA) regulates pharmaceuticals, biologics, veterinary products, herbal medicines, and health supplements. Its core functions include product registration, safety and efficacy assessment, GMP inspection, lab testing, pricing regulation, and post-market surveillance.

FAQ 2: Who is eligible to apply for drug registration in Saudi Arabia?

Only a local Marketing Authorization Holder (MAH)—either the manufacturer’s affiliate or a licensed agent in the Kingdom of Saudi Arabia- can submit registration applications. The MAH is legally responsible for maintaining the registration and ensuring product compliance.

FAQ 3: What types of products fall under SFDA regulation?

The SFDA regulates:

  • Prescription and OTC human drugs
  • Biologics and biosimilars
  • Herbal and traditional medicines
  • Veterinary pharmaceuticals
  • Radiopharmaceuticals and vaccines

Each product type has its own registration and dossier requirements.

FAQ 4: Are there expedited or abridged approval pathways?

Yes. SFDA offers multiple routes to reduce registration time, including:

  • Abridged review (based on reference authority approvals like EMA/FDA)
  • Priority review
  • Conditional approval
  • Orphan drug pathway

FAQ 5: What documents are required for drug registration with the SFDA?

The SFDA follows the CTD (Common Technical Document) format. Module 1 (region-specific) must include:

  • Application form
  • SPC and labeling (English/Arabic)
  • GMP and CPP certificates
  • Risk Management Plan
  • Pricing file
  • Local lab test samples (if required)

FAQ 6: Are local stability studies or lab testing mandatory?

Yes. The SFDA typically requires:

  • Local lab testing of submitted product samples
  • Regional stability data, aligned with GCC guidelines

FAQ 7: What are the average timelines for SFDA approval?

Estimated timelines include:

  • New drugs/biologics: 12–18 months
  • Generics: 6–12 months
  • Abridged submissions: shorter, based on completeness of foreign approval data

FAQ 8: Is pharmacovigilance required in Saudi Arabia?

Absolutely. The SFDA mandates:

  • Appointment of a Qualified Person for Pharmacovigilance (QPPV)
  • Submission of Risk Management Plans (RMPs)
  • Timely reporting of adverse events to the National Pharmacovigilance Center

FAQ 9: Are GMP inspections required by SFDA?

Yes. While SFDA may accept GMP certificates from Regulatory authorities like EMA, FDA, or TGA, it reserves the right to conduct its own GMP inspections, especially for high-risk or high-priority products.

FAQ 10: How long is a registration valid, and how is it renewed?

Marketing authorizations are valid for five years. Renewal applications must be filed at least six months before expiry, and sponsors must also keep SFDA informed of post-approval changes, including variations in manufacturing, labeling, or safety.

Final Thoughts

Understanding the FAQs surrounding SFDA drug regulation is critical for timely and successful product registration. From CTD dossier development and lab testing to pricing and pharmacovigilance, each step plays a pivotal role in ensuring compliance with Saudi Arabia's evolving Regulatory landscape.

Reach out to our expert team at Freyr for end-to-end Regulatory support, including strategy, submission, and post-market lifecycle management.