CMC Guidance for Human Gene Therapy Clinical Trial Applications
SFDA Issues Final CMC Guidance for Human Gene Therapy Clinical Trial Applications.
Regulinked
- November 7, 2025
- Consulting
- No Comments
Author: Regulinked
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
Oman MOH – Mandatory Renewal of Pharmaceutical Licenses via the Electronic Health Portal (EHP)
OMAN MOH issued new Circular No. 194/2025 – Mandatory Renewal of Pharmaceutical
- October 14, 2025
- Guideline
- No Comments
Guideline on the Preparation & Submission of eCTD Dossiers – Kuwait
Kuwait MoH issues “Guideline on the Preparation & Submission of eCTD Dossiers”
- October 9, 2025
- Guideline
- No Comments
Braille Requirements for Labeling Information – Qatar
Qatar MOPH issues new Guideline on Braille Requirements for Labeling Information of
- October 9, 2025
- Guideline
- No Comments
SFDA issues “Good Review Practices (GRevPs)” Guideline Version 1.0
SFDA issues “Good Review Practices (GRevPs)” Guideline Version 1.0 🔍 What’s new:
- October 3, 2025
- Guideline
- No Comments
Kuwait MOH Approved pricing for 69 Medicines in Private Pharmacies
The Kuwait Ministry of Health has issued Price Resolution No. 93/2025, approving
- September 14, 2025
- Consulting
- No Comments
SFDA updates – Guideline of Data Requirements for Human Drug Submissions – Version 4.0
SFDA publishes Version 4.0 of Data Requirements for Human Drug Submissions (August
- September 14, 2025
- Guideline
- No Comments
SFDA updates – Guideline on Good Pharmacovigilance Practices (GVP)
SFDA Just publish new updates regarding Guideline on Good Pharmacovigilance Practices (GVP)
- September 12, 2025
- Guideline
- No Comments
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