SFDA Expands Drug Track & Trace to Fight Fakes

The Saudi Food and Drug Authority is expanding its national digital pharmaceutical traceability platform, the Drug Track and Trace System (RSD), to strengthen medicine safety and curb counterfeit drugs across the Kingdom. The system monitors every human medicine made in or imported into Saudi Arabia, from production or import all the way to final dispensing.

Under the rules, every pharmaceutical pack must carry a serialized 2D DataMatrix barcode encoding at minimum the global trade item number (GTIN), a unique random serial number, the batch or lot number, and the expiry date. Each pack is linked to the establishment through a Global Location Number, enabling end-to-end tracking as products move through the supply chain.

All stakeholders — manufacturers, importers, wholesalers, distributors, pharmacies, and healthcare facilities — must register and integrate their systems with RSD and report drug movement events such as production, import, receipt, distribution, dispensing, recall, and blocking in near real time or within 24 hours. The platform also uses aggregation, grouping packs into cartons and pallets, to create detailed digital records of how medicines are transported.

Why it matters to residents

For the public, the biggest benefit is a simple safety check. Anyone can scan the DataMatrix code on a medicine pack using the SFDA mobile application to confirm whether the product is registered, blocked, recalled, or expired — an easy way to spot counterfeit or unsafe medicines before use.

The system, first launched in late 2018, now records more than one billion supply-chain operations and is used to stop recalled or blocked medicines from reaching patients. Officials describe pharmaceutical traceability as being in full enforcement across the Kingdom, with an updated infrastructure and the launch of RSD 2.0 improving inventory visibility and performance. The requirements apply specifically to human drugs, while veterinary medicines follow separate regulatory tracks.

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