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Regulatory Editor

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  • How to develop and submit RMP & RMM to SFDA?

    Understanding RMP & RMMs in SFDA PV Regulation

  • Drug Scientific-Office in Saudi Arabia, what is required and when?

    Scientific Office License Requirements by SFDA

  • How to apply for breakthrough medicine designation

    Breakthrough Medicines Designation in SFDA

  • PSSF in SFDA

    Saudi Pharmacovigilance Subsystem File (PSSF)

  • 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

  • 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

  • The new route of registration for low risk medical device

    SFDA Sunsets the MDNR Procedure for Low-Risk Medical Devices

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

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

  • NDLP: Saudi Pharmaceutical Market is expected at $11.7 billion by 2030 (Medical Devices Included)

  • UDI services SFDA

    UDI Data Submission to SFDA for Medical Devices

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