Guideline - Regulinked.com

NHRA – updated “International Manufacturing Site Licensing Procedure”

NHRA issues updated “International Manufacturing Site Licensing Procedure” Guideline (Version 1.6)

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November 10, 2025
Guideline
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CMC Guidance for Human Gene Therapy Clinical Trial Applications

SFDA Issues Final CMC Guidance for Human Gene Therapy Clinical Trial Applications.

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November 7, 2025
Consulting
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SFDA- “Verification & Abridged Pathways” Guideline updates

SFDA issues updated “Verification & Abridged Pathways” Guideline (Version 3.0 — Issued

SFDA- Approach of Dealing with Patents When Registering Generic Drugs in SFDA Guideline

The Saudi Food & Drug Authority (“SFDA”) has issued a new guidance

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October 23, 2025
Guideline
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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

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October 14, 2025
Guideline
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Guideline on the Preparation & Submission of eCTD Dossiers – Kuwait

Kuwait MoH issues “Guideline on the Preparation & Submission of eCTD Dossiers”

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October 9, 2025
Guideline
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Braille Requirements for Labeling Information – Qatar

Qatar MOPH issues new Guideline on Braille Requirements for Labeling Information of

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October 9, 2025
Guideline
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SFDA issues “Good Review Practices (GRevPs)” Guideline Version 1.0

SFDA issues “Good Review Practices (GRevPs)” Guideline Version 1.0 🔍 What’s new:

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October 3, 2025
Guideline
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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

Regulinked
September 14, 2025
Guideline
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SFDA updates – Guideline on Good Pharmacovigilance Practices (GVP)

SFDA Just publish new updates regarding Guideline on Good Pharmacovigilance Practices (GVP)

Regulinked
September 12, 2025
Guideline
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Category: Guideline