The Saudi Food & Drug Authority (SFDA) has released Version 6.4 of its Regulatory Framework for Drug Approval, introducing key updates that streamline the process for new Marketing Authorization Applications (MAA), variations, and renewals. This comprehensive document is designed to guide pharmaceutical companies and stakeholders through every stage of drug registration in Saudi Arabia.

SFDA Vision and Mission

Vision: To be a leading international science-based regulator to protect and promote public health.

Mission: Protecting the community through regulations and effective controls to ensure the safety of food, drugs, medical devices, cosmetics, pesticides, and feed.

What’s New in Version 6.4

The latest update introduces several significant improvements:

• Updated Sections:
  • Marketing Authorization Application (MAA): Enhanced submission and assessment procedures, including performance targets for regular, priority, and abridged pathways.
  • Variation of MAA: Clearer rules on minor (Type IA, IB) and major (Type II) variations, rejection cases, and timelines.
  • Renewal of MAA: Shorter and more streamlined renewal process.
• New Addition:
  • Breakthrough Medicine Designation Program – a fast-track pathway for drugs addressing serious or life-threatening conditions with unmet medical needs.
• Removed:
  • Old appendix for variation application forms (replaced by electronic SDR system process).

Key Processes Under the Framework

1. New Marketing Authorization Application (MAA)

Steps for Submission and Approval:

1. Online Submission: Applicants submit via the SDR system, upload the product file (CTD format), and pay the required fees.
2. Validation:
   • Technical Validation: Automatic SDR check.
   • Business Validation: Manual review; applicants must respond to any inquiries within 30 working days or risk rejection.
3. Assessment:
   • Evaluation & Inspection: Quality, safety, efficacy reviews and GMP inspections if needed.
   • Testing: Conducted by SFDA Central Labs (does not delay registration).
4. Pricing: Product price reviewed according to SFDA’s pricing rules.
5. Product Licensing: Final decision by the Registration Committee and SFDA CEO.

Performance Targets:

• Regular Pathway: 155–405 working days (depending on product type).
• Priority Pathway: 40% faster timelines for critical medicines.
• Verification & Abridged Pathway: 30–60 working days.

2. Breakthrough Medicine Designation

A program to accelerate development and review of drugs for serious diseases with limited treatment options. It involves early dialogue with SFDA to optimize development plans and ensure quicker patient access.

3. Variation of Marketing Authorization

Companies must submit any changes to registered products via the SDR system:

• Type IA (Do & Tell): Minor changes – notify SFDA within 14 days after implementation.
• Type IB (Tell, Wait & Do): Minor changes needing SFDA confirmation (60 working days).
• Type II: Major variations that require SFDA approval before implementation.

Applicants have up to 3 waves of communication per application. Non-response or unsatisfactory responses lead to rejection.

4. Renewal of Marketing Authorization

• Required every five years.
• Submission must be made within six months of expiry.
• Faster process through SDR system, with a 40-working-day total performance target (excluding business validation hold times).
• Rejected renewals require a new submission.

Applicant Responsibilities

• Respond Timely: 30 working days for validation inquiries, 60 working days for assessment inquiries.
• Follow SFDA Guidelines: Submissions must meet all technical and regulatory requirements.
• Monitor SDR System: All notifications and decisions are communicated electronically.
• Appeal Rights: Applicants can appeal decisions within 60 calendar days.