の サウジアラビア食品医薬品局（SFDA） published updated product classification guidance の上 January 20, 2026, clarifying regulatory requirements for products regulated under its jurisdiction. The guidance, which became applicable on November 20, 2025, outlines how products across multiple sectors are classified and submitted through the e-GHAD platform.
The update applies to companies involved in manufacturing, importing, or marketing products such as food, drugs, medical devices, cosmetics, animal care products, tobacco, feed, and pesticides in Saudi Arabia. It introduces revised category definitions, updated documentation requirements, and procedures for combination and innovative products to help streamline classification processes.
アップデートの詳細
改訂されたガイダンスでは、 product classification decisions must be obtained through the e-GHAD platform, and each classification approval remains valid for one year from the date of issuance.
For all classification applications, companies must submit supporting documentation, including details about the product’s claims, mechanism of action, and intended use. These elements are used by the authority to determine the correct regulatory category.
The guidance also explains that products making medicinal claims or containing ingredients above specified limits may be reclassified as drugs or health products. This provision reinforces the need for careful review of claims and ingredient thresholds during product development and registration.
Specific clarification is provided for 化粧品, which must be limited to external use only and must not contain therapeutic substances or therapeutic claims.
Additionally, the guidance outlines procedures for innovative product submissions. Independent inventors submitting innovative products are exempt from classification fees, provided that patent certificates are included with the application.
アン appeal process is also available for stakeholders who wish to challenge a classification decision. Appeals must be submitted within 30 days of receiving the classification outcome.
発効日
更新された SFDA product classification guidance became final on November 20, 2025, and applies すぐに に all new and ongoing classification applications 提出済み を通して e-GHAD platform.
なぜそれが重要なのか
The updated guidance improves 規制の明確さ by refining definitions for product categories and establishing clear documentation requirements for classification applications. By standardizing submissions through the e-GHAD platform, the framework also supports digital regulatory processes, enabling more efficient classification workflows while maintaining oversight across multiple regulated sectors.
誰に関係があるか
このアップデートは、 regulatory affairs, quality assurance, product development, and compliance teams, as well as organizations responsible for market authorization, product classification, and regulatory submissions in Saudi Arabia.
次のステップ
Organizations should review their existing product portfolios against the revised classification definitions and documentation requirements outlined in the guidance. Products that include medicinal claims, specific ingredient levels, or combination functionalities may require reclassification or additional supporting documentation.
Regulatory teams should also coordinate with R&D, quality, and commercial teams to ensure all required materials are prepared for submission through the e-GHAD platform, and monitor future annual updates to the guidance that may introduce further compliance requirements.
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よくある質問
What is the SFDA product classification guidance update?
の SFDA product classification guidance update, published on January 20, 2026, clarifies how products regulated by the authority must be classified and 提出済み を通して e-GHAD platform, including revised definitions and documentation requirements.
How long is an SFDA product classification valid?
あ classification decision issued through the e-GHAD platform は valid for one year from the date of approval.
Can a product be reclassified under the updated SFDA guidance?
Yes. Products with medicinal claims or ingredient levels exceeding specified limits may be reclassified as drugs or health products, depending on their characteristics and intended use.
どうすれば RegASK help companies manage SFDA regulatory updates?
RegASK helps regulatory and compliance teams monitor global regulatory changes, interpret classification and submission requirements, and streamline compliance workflows using agentic AI combined with expert oversight, enabling organizations to respond more efficiently to updates such as the SFDA product classification guidance.
