SFDA has issued Regulatory Guide for SFDA Services in Duty- and Tax-Suspended Zones
SFDA has issued a new regulatory guide clarifying the services and requirements
Regulinked
- July 28, 2026
- Acceleration process
- No Comments
Tag: SFDA
SFDA published six guidelines regarding classification of violations and associated penalties
SFDA has published six guidelines regarding classification of violations and associated penalties
- July 28, 2026
- Acceleration process
- No Comments
SFDA Issues “Guidelines for Chemical and Pharmaceutical Quality Documentation of Small Molecules Investigational Products in Clinical Trials” (Version 1.0)
Saudi Food and Drug Authority (SFDA) has issued Version 1.0 of new
- March 21, 2026
- Acceleration process
- No Comments
SFDA Issues Updated Guidance on “Combination Products Classification and Registration” (Version 2.0)
SFDA has issued Version 2.0 of the “Guidance for Combination Products Classification
- March 15, 2026
- Acceleration process
- No Comments
SFDA – “Products Classification Guidance” V 9.0
SFDA has issued Version 9.0 of the “Products Classification Guidance”, introducing updated
- February 12, 2026
- Acceleration process
- No Comments
SFDA- “Clinical Considerations for Vaccines” V 2.0
SFDA issued the updated “Clinical Considerations for Vaccines” guideline – Version 2.0
- February 12, 2026
- Acceleration process
- No Comments
SFDA- “Guideline on Requirements for Advertising and Promotion of Pharmaceutical and Herbal Products” V 7.0
The Saudi Food & Drug Authority (“SFDA”) has issued V 7.0 of
- January 27, 2026
- Guideline
- No Comments
CMC Guidance for Human Gene Therapy Clinical Trial Applications
SFDA Issues Final CMC Guidance for Human Gene Therapy Clinical Trial Applications.
- November 7, 2025
- Consulting
- No Comments
SFDA- “Verification & Abridged Pathways” Guideline updates
SFDA issues updated “Verification & Abridged Pathways” Guideline (Version 3.0 — Issued
- October 31, 2025
- Acceleration process
- No Comments
SFDA- Approach of Dealing with Patents When Registering Generic Drugs in SFDA Guideline
The Saudi Food & Drug Authority (“SFDA”) has issued a new guidance
- October 23, 2025
- Guideline
- No Comments
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