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Biotech

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  3. Biotech
  • orphan drug in Saudi Arabia

    Orphan Drug Designation (ODD) in SFDA

  • 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 and Stringent Authorities

  • How to submit a safety report ICSR to SFDA

    Submission of Individual Case Safety Reports (ICSRs) to SFDA

  • Signal Management Workshop (March 2023 Riyadh)

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

    Periodic Safety Update Report (PSUR) Submission to SFDA

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

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

  • Clinical trials CRO requirements

    SFDA Clinical Trials Requirements in Saudi Arabia

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