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-Dept@sfda.gov.sa
Fax Number:
(+966)-1-275-7195
Mail address:
Drug Sector
Saudi Food and Drug Authority (SFDA)
P.O. Box 84983 Riyadh 11681
Kingdom of Saudi Arabia

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• Saudi National Drug Code-Draft(New) 
• Regulatory Framework for Drug Approvals -Draft
• Institutions and Pharmaceutical Products Law 
• Executive Roles for Institutions and Pharmaceutical Products Law 
• Narcotic Regulations
• Narcotic Guidelines
• Drugs Companies and Its Products Registration Guideline.
• Herbal Products & Food Supplements Companies. 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
  - PMS Guidelines for Human Drugs 
  - PMS Guidelines for Veterinary Drugs 
• Good Laboratory Practice (GLP) Guidelines *
• Clinical Trials Guidelines *
• Bioequivalence Guidelines  *
Stability Guidelines 
• Drug Master File Requirements for Registration of Biosimilars (new)

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.