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Monday, April 11, 2011

Regulations & Guidelines(Saudi Food and Drug Authority)

Guidelines for biologicals:


    • (new)
  • Data Requirements Update for Herbal & Veterinary Products (New)
  • (Requirements and Documents for Clearing Cosmetic Products from Customs Ports (update
  • (Guidelines for Process Validation of Pharmaceutical Dosage Forms (new
  • (Quality Guidelines for Chemistry and Manufacturing (new
  • (Guidance for Presenting the SPC, PIL and Labeling information (new
  • (Guidance for the Preparation of a Site Master File (SMF) (new
  • (Guidelines on Biosimilars (update
  • (Pharmaceutical Product Analysis Application Form (new
  • Guidelines for Investigational New Drugs (IND) Requirements(new)
  • Guideline for Pharmaceutical Equivalence Requirements (new)
  • (Policy Guidance for Pharmaceutical Reference Standard(new
  • Guidelines for Drug Master File(DMF) (new)
  • Policy guidance for Lot Release of Biological Products (new)
  • Policy Guidance for Certificate of Suitability (new)
  • Guidelines for Variation Requirements (new)
  • Regulatory Framework for Drug Approvals v 4
  • Guidance for Submission v 2
  • Institutions and Pharmaceutical Products Law
  • Executive Roles for Institutions and Pharmaceutical Products Law

  • Drugs Companies and Its Products Registration Guideline
  • Guidelines for Good Manufacturing Practice of Radiopharmaceuticals
  • Manufacturing and Compounding of Medications in Pharmacies and Hospitals Guidelines
  • Good Manufacturing Practice (GMP) Guidelines

    Post-Marketing Surveillance (PMS) Guidelines :


  • - The SFDA Responsibility in PMS


  • -Saudi Pharmacovigilance Guideline Of Registered Medicines for Human Use (new)


  • - PMS Guidelines for Veterinary Drugs

  • Good Laboratory Practice (GLP) Guidelines
  • Clinical Trials Requirement Guidelines (new)
  • Bioequivalence Guidelines (new)
  • Stability Guidelines (new)
    • Drug Master File Requirements for Registration of Biosimilars (update)
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