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

🔍 Summary:
The Saudi Food and Drug Authority (SFDA) has published Version 1.0 of its guideline addressing the regulatory requirements for Chemistry, Manufacturing, and Control (CMC) information in Human gene therapy Clinical Trial Applications (CTAs) submitted to the SFDA.
The objective of this document is to provide clear guidance on the CMC requirements for investigational human gene therapies to ensure that such products meet appropriate levels of quality and safety for clinical studies.

📌 Key details:

• Implementation date: 1 February 2026.
• Human gene therapy products are classified as Biological Products under SFDA guidelines.
• The Clinical Trial Application must contain sufficient CMC information to assess the risks to subjects, If the information is deemed insufficient, the SFDA may place the product on Clinical Hold (temporarily stopping the trial).
• Applicants are advised to organize and categorize their CMC information in an Investigational Product (IP) Dossier and follow the structure of the electronic Common Technical Document (eCTD) Module 3.
• Any necessary manufacturing changes must be submitted to the SFDA for review and approval prior to implementation, maintaining control over product quality.

🔗 Full guideline (PDF): Gene Therapy CMC Requirements for Clinical Trails

📌 Note:
At ReguLinked, we’re committed to keeping partners and industry professionals informed about evolving regulatory expectations across the region. Our team will continue monitoring SFDA releases to support proactive compliance planning and regulatory readiness.

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📨 Get in touch: bd@regulinked.com | 🌐 www.regulinked.com

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