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Author: المحرر التنظيمي

Published by regulatory affairs team in PharmaKnowl, Riyadh office.
  • SFDA Patent Rules for Generic Drugs

    Saudi Genric Drug Patent Regulations (SFDA FTO)

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    What are the eCTD Requirements in SFDA?

  • PharmaKnowl at the Global Health Exhibition 2025

  • Exhibiting at the World Drug Safety Congress, Amesterdam 2025

  • We are exhibiting in the 24th ISoP Annual Meeting, in Cairo

  • Medical Device Establishment License (MDEL) in SFDA

    Medical Device Establishment License (MDEL)

  • SFDA preclinical study submission process in Saudi Arabia

    Preclinical Studies Submissions to SFDA

  • Step-by-step SFDA Drug Master File submission and approval process

    Drug Master File (DMF) & Letter of Access for SFDA

  • Overview of SFDA-accepted economic activities linked to commercial records for regulatory operations

    Commercial Record Economic Activities Accepted by SFDA

  • Illustration of Literature-Based Submission in SFDA

    Literature-Based Submissions in SFDA

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