Regulations & Guidelines

Guidelines and practical directions represent the primary suggested draft, which has been prepared by the practical team to enable the SFDA to prove these Guidelines and regulations after referring to the opinions of concerned authority and concerned professions.

Please provide us your suggestions and feedback about these guidelines and practical directions to one of the following addresses:

E-Mail:
drug.comments@sfda.gov.sa

Fax Number:
009661 205 7637

Mail address:
SFDA - 3292 North Highway Al Nafal Unit (1) - Riyadh 13312 - 6288

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Guidelines for biologicals:


  (new)

 




    • Data Requirements for Human Drugs Submission (new)

    Frequently Asked Question for Temperature Monitors(new)
  • RevAssist Program for Lenalidomide
    •      (new)
  • Data Requirements for Herbal and Health products submission(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
  • Policy guidance for Lot Release of Biological Products (new)
  • Policy Guidance for Certificate of Suitability (new)
  • Guidelines for Variation Requirements 
  • Regulatory Framework for Drug Approvals v 4 
  •  Guidance for Submission v 3 (new)
  • GCC Module1 Specifications  (new)
  • Institutions and Pharmaceutical Products Law 
  • Executive Roles for Institutions and Pharmaceutical Products Law 
  • Narcotic Regulations
  • Narcotic Guidelines
  • 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)

     

     

    • Drug marketing :
      Saudi code of pharmaceutical promotional practices in the kingdom of saudi arabia ( soon )

     

  • Products Classification

                Guidance for Products Classification(draft)

  • Cosmetic Pharmaceutical

    • Products     
    • Cosmetic Pharmaceutical Products Guidelines.
    • Cosmetic Pharmaceutical Products Regulations.
    • Registration of Cosmetic Pharmaceutical Products companies and their products.

     

    Veterinary Medicines 

    • Guidelines of Institutions and cosmetic pharmaceutical products.
    • Regulations of Institutions and cosmetic pharmaceutical products.
    • Regulations of the Registration of veterinary medications companies and their  products.
    • Guidelines of the Registration of veterinary medications companies and their products.


     

    * Primary Draft for comments.