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  • How to apply for breakthrough medicine designation

    Breakthrough Medicines Designation in SFDA

  • PMCF in Saudi Arabia as per SFDA

    Implementing PMCF Study for Medical Devices in Saudi Arabia

  • Saudi Drug Information (SFDA SDI)

    Drug Information and Stock Reporting to SFDA (SDI) Platform

  • PSSF in SFDA

    Saudi Pharmacovigilance Sub System File (PSSF)

  • SFDA recall procedure in Saudi Arabia

    Product Recall in Saudi Arabia

  • SDEA-Requirements-by-SFDA

    SDEA Agreement Requirements by SFDA

  • The registration timelines in SFDA for all types of products.

    SFDA Timelines

  • What are the reference countries in SFDA?

    SFDA Reference Countries

  • How to submit a safety report ICSR to SFDA

    Submission of Individual Case Safety Reports (ICSRs) to SFDA

  • How to submit a PSUR to SFDA and what are the requirments?

    Periodic Safety Update Report (PSUR) Submission to SFDA

  • Medicinal gas registration in Saudi as a medical device

    Medical Gas Registration

  • Product label and artwork requirements in Saudi Arabia according to SFDA.

    SFDA Labelling Requirements (SPC, PIL, IFU, Artworks)

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