Priority Review Revision:

The SFDA removed the “first generic” criterion from its Priority Review program (v5.3), focusing on selected human, veterinary, and biosimilar products for expedited evaluation.

Conditional Approval Framework:

A new approval pathway allows provisional authorization of innovative treatments for up to two years (potentially extendable twice), streamlining early access for serious or life-threatening conditions.

Herbal & Health Products Requirements (v3.0):

Enhanced dossier obligations now mandate patent status declarations and detailed marketing authorization holder information.

Preclinical Studies Guidance (v1.0):

Outlines the minimum non-clinical data required for clinical trials, marketing authorizations, and variation applications, reinforcing SFDA’s safety and efficacy standards.

Product Classification Guidance (v7.0):

Updates classification rules for raw materials, food supplements, custom-made medical devices, and certain unregistered products, clarifying regulatory pathways and labeling responsibilities.

In-House IVDs Guidance (MDS-G022):

Details quality management and performance criteria for laboratory-developed in vitro diagnostic devices, emphasizing proper design, risk assessment, and post-market surveillance.

Surgical Sutures & Biotech-Based Devices:

Additional guidance (MDS-G021 and MDS-G016) clarifies compliance requirements, design considerations, and safety standards for sutures and biotechnology-driven medical devices.

Good Manufacturing Practice for Blood Establishments (v3.0):

Revised definitions, donor eligibility protocols, and data-processing requirements ensure a more robust quality management system for blood and blood components.

Defines the process and documentation required for initiating clinical studies in Saudi Arabia.

Clarifies roles and responsibilities for sponsors, investigators, and authorized representatives.

Details the procedures for clinical trial applications, approvals, monitoring, reporting, and final submission of results.

Emphasizes compliance with ISO 14155 for clinical investigations involving medical devices.

Applies to all medical devices and supplies requiring clinical data to demonstrate safety and performance.

For CE Certificates under MDR:

The following documentation is acceptable for covering the legal and/or actual manufacturer:

1. ISO 13485:2016 certificate (must cover either the legal or actual manufacturer)
2. GMP Certificate clearly showing compliance with ISO 13485:2016 requirements (must verify ISO equivalence)

For CE Certificates under MDD, CE Extension, or Self-Declaration:

One of the following must be submitted:

1. ISO 13485:2016 certificate
2. GMP certificate confirming alignment with ISO 13485:2016 issued by a recognized body

Certificate Verification Requirements

To ensure that the submitted certificate covers the actual manufacturing site, one of the following forms of verification is required:

1. The actual manufacturer’s name and address must be clearly stated in the certificate.
2. A supporting letter from the issuing authority must confirm that the certificate applies to the actual manufacturer.
3. A direct confirmation must be sent from the certifying body to EDA.

Accelerating processing times through automated workflows

Enabling 24/7 submission access for licensed agents

Providing real-time application tracking

Ensuring data accuracy through centralized documentation

Clearance Documentation: Healthcare providers must submit the bill of lading with the clearance request

Regulatory Coordination: Any conditions affecting medication availability must be addressed by the drug store and the pharmaceutical companies, ensuring therapies remain accessible in the market without undue restrictions.

Enforcement Timeline: Full compliance is mandatory by July 1, 2025, to prevent delays or regulatory penalties.

Clearance Documentation: Healthcare providers must submit the bill of lading with the clearance request

Regulatory Coordination: Any conditions affecting medication availability must be addressed by the drug store and the pharmaceutical companies, ensuring therapies remain accessible in the market without undue restrictions.

Enforcement Timeline: Full compliance is mandatory by July 1, 2025, to prevent delays or regulatory penalties.

Comprehensive Revisions: The latest version features in-depth updates that clarify the classification landscape for products under SFDA oversight. By establishing more detailed guidelines, the SFDA seeks to reduce ambiguity and ensure smoother regulatory pathways for industry stakeholders.

Emphasis on Medical Comprehensive Revisions: The latest version features in-depth updates that clarify the classification landscape for products under SFDA oversight. By establishing more detailed guidelines, the SFDA seeks to reduce ambiguity and ensure smoother regulatory pathways for industry stakeholders.

Devices and IVD Products: Recognizing the critical role these products play in healthcare, Version 7 places special focus on refining classification standards for medical devices and IVD products. Strengthened guidelines aim to uphold product safety and efficacy within the Saudi market.

Implications for the Healthcare Industry:

1. • Efficiency Gains: By providing more precise classification criteria, the SFDA anticipates a more efficient regulatory process, benefitting manufacturers, distributors, and other industry participants.
   • Enhanced Compliance: Clearer product categorization requirements are expected to facilitate alignment with SFDA standards and international best practices, supporting product quality and patient safety.

Collaborative Regulatory Environment: Building on extensive feedback from manufacturers, industry experts, and other stakeholders, the SFDA continues to promote an inclusive approach to regulation. Version 7 reflects this collective effort, underscoring the Authority’s commitment to evolving its frameworks in tandem with global standards.

 Technical application – feasible embossing  laser or ink-jet solutions for Braille on cartons, wallets and tubes.

Product limitations – dosage forms or pack sizes where Braille may be impractical.

Minimum data set – key information (e.g. product name, strength, dosage form) that should appear in Braille by product class.

Transition plan – realistic timelines for:​

1. • medicines already registered in Qatar
   • medicines in the pipeline or newly submitted.

Comment deadline Feedback must reach MOPH by 30 June 2025. Responses should outline anticipated challenges, line-equipment requirements and any knock-on effects for artwork lead times.

Regional context The Saudi Food & Drug Authority (SFDA) is already implementing a phased Braille programme—2026 for newly registered products and 2028 for those already on the market. A GCC-wide harmonised guideline is therefore expected.

This designation underscores the potential of Itovebi as an add-on therapy to the palbociclib and fulvestrant regimen to address significant unmet medical needs in oncology, particularly for patients who have limited treatment options due to resistance to conventional hormone therapies.

The Breakthrough Designation is part of the SFDA's strategic initiative to expedite the development and review of drugs that demonstrate substantial improvement over existing therapies. By facilitating a more efficient regulatory pathway, the SFDA aims to ensure that promising treatments like Itovebi reach patients more swiftly, thereby enhancing clinical outcomes and quality of life for individuals battling advanced stages of breast cancer.

This development aligns with global efforts to accelerate the availability of critical medical innovations and reflects the SFDA's commitment to supporting advancements in cancer treatment. Healthcare professionals and stakeholders are encouraged to monitor further updates regarding Itovebi's clinical progress and regulatory status.