Regulations & Guidelines(Saudi Food and Drug Authority)

Guidelines for biologicals:

• Blood Products.
• Vaccines.
• Antisera.
• Allergenic Products.
• 
  

• Frequently Asked Question for Temperature Monitors(new)

RevAssist Program for Lenalidomide

(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)