Saudi Arabia Pharma Traceability Requirements: Complete SFDA RSD (DTTS) Compliance Guide 2026

Complete guide to Saudi Arabia pharmaceutical traceability regulations. Learn SFDA RSD (DTTS) serialization, aggregation, GS1 standards, reporting obligations, and compliance timelines.

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Introduction: Saudi Arabia Pharmaceutical Traceability Framework

Saudi Arabia implemented mandatory pharmaceutical traceability under the supervision of the Saudi Food and Drug Authority (SFDA) as part of its Vision 2030 healthcare modernization strategy. The system, known as RSD (رصد) or DTTS (Drug Track & Trace System), requires every pharmaceutical product distributed in the Kingdom to be serialized, aggregated, and digitally reported throughout the supply chain.

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SFDA RSD Requirements Overview (2026)

Saudi Arabia pharmaceutical traceability requirements include:

• Mandatory serialization at secondary packaging level
  
• 2D DataMatrix barcode (GS1 ECC 200)
  
• Random serial number generation
  
• Aggregation using GTIN & SSCC identifiers
  
• GLN registration for  relevant stakeholders, such as Manufacturers, Distributors and Wholesaler etc
  
• Real-time or 24-hour reporting of supply chain events
  
• End-to-end chain of custody visibility

Failure to comply can prevent product importation, distribution, or dispensing.

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Understanding the SFDA RSD System (DTTS)

What Is RSD?

RSD is Saudi Arabia’s national pharmaceutical track and trace platform operated by SFDA. It creates a digital lifecycle record for each serialized pharmaceutical unit from production or import to final dispensing or consumption.

Unlike traditional inventory systems, RSD enforces regulatory reporting of every supply chain transaction.

RSD System Architecture

Saudi Arabia’s traceability ecosystem consists of three components:

1. RSD Stakeholder Management Portal

Used for:

• Company registration
  
• GLN activation
  
• GTIN registration
  
• User management
  
  

2. RSD Stakeholder Operation Portal

Used for:

• Real-time event reporting (Supply, Dispatch, Accept, Import, etc.)
  
• Transaction confirmations
  
• Compliance monitoring
  
  

3.  PTS (Package Transfer System)

Used for:

• Bulk file upload
  
• Aggregation reporting
  
• High-volume reconciliation
  

High-volume stakeholders typically require integration with both DTTS and PTS. The concerned stakeholders will transfer the Commissioning and Aggregation EPCIS files through PTS, and the relevant stakeholders can download the transferred EPCIS files from PTS as required.

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Serialization Requirements in Saudi Arabia

Serialization is mandatory for every pharmaceutical product distributed in Saudi Arabia.

Each secondary package must carry a unique identifier encoded in a GS1-compliant 2D DataMatrix barcode.

Mandatory Data Elements

• GTIN-14 (product identifier)
  
• Serial Number (randomized, unique per unit)
  
• Batch/Lot Number
  
• Expiration Date (YYMMDD)
  
  

The barcode must:

• Follow GS1 ECC 200 standards
  
• Meet ISO/IEC 15415 Grade C minimum
  
• Include human-readable data
  
• Be tamper-evident

Serial numbers must be random and non-sequential.

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Aggregation Requirements in Saudi Arabia Pharma

Aggregation became mandatory in August 2020. Aggregation links serialized cartons to higher packaging levels (cases and pallets) using GTIN & SSCC (Serialized Shipping Container Code). This creates a parent-child packaging hierarchy and enables bulk reporting.

As per the DTTS requirements, Aggregation reporting is not mandatory. Only the Least Saleable Unit (LSU) commissioned serial numbers are required to be reported to DTTS. However, manufacturers can still maintain the aggregation hierarchy (e.g., unit → case → pallet) internally for supply chain traceability purposes.

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Key Aggregation Identifier

SSCC (18-digit GS1 code) -  Used to identify logistics units such as:

• Cases
  
• Pallets
  
• Shipping containers

Aggregation improves operational efficiency while ensuring regulatory compliance.

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GS1 Standards & Technical Specifications

Saudi Arabia’s traceability framework is built on GS1 global standards.

Required GS1 Identifiers

• GS1 Company Prefix
  
• GTIN-14
  
• GLN (Global Location Number)
• SSCC

DataMatrix Structure

The required barcode format:

• (01) GTIN
• (21) Serial Number
• (17) Expiration Date
• (10) Batch Number

Symbol Type: ECC 200
Minimum Print Quality: Grade C

These standards ensure global interoperability with other regulatory frameworks.

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Who Must Comply With SFDA Traceability Requirements?

The following stakeholders must comply:

• Local manufacturers
  
• Foreign manufacturers exporting to Saudi Arabia
  
• Importers
  
• Wholesalers and distributors
  
• Retail pharmacies
  
• Hospitals and clinics

All must register GLNs and report RSD transactions relevant to their role.

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RSD Reporting Requirements

All stakeholders must report defined transaction events to SFDA.

Core Reporting Operations

• Supply / Import
  
• Dispatch
  
• Accept
  
• Pharmacy Sale
  
• Consume (hospitals)
  
• Deactivate
  
• Return
  
• Transfer

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Reporting Methods

• API integration (recommended for high-volume operations)
  
• PTS bulk file upload
  
• Manual portal entry (limited use)
  
  

Reporting deadlines range from real-time (pharmacy sale) to within 24 hours for other events.

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Implementation Timeline

Saudi Arabia’s serialization rollout began in 2017, with phased enforcement completed by 2020.

Key milestones include:

• 2017: Initial serialization announcement
  
• 2019: Full supply chain go-live
  
• August 2020: Aggregation mandatory
  
• 2025: Full enforcement and mature ecosystem
  
  

New market entrants must comply from Day 1.

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Compliance Checklist for 2026

Organizations should ensure:

• GS1 Company Prefix registration
  
• GTIN assignment and RSD registration
  
• GLN activation for all facilities
  
• Serialization capability
  
• Aggregation implementation
  
• RSD API or PTS integration
  
• Internal SOP alignment
  
• Ongoing reconciliation processes
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Frequently Asked Questions

1. What is pharmaceutical traceability in Saudi Arabia?

Pharmaceutical traceability in Saudi Arabia refers to the SFDA-operated RSD (Rasd) system, also known as DTTS. It requires every pharmaceutical unit to be serialized using GS1 standards and reported digitally throughout the supply chain to ensure authenticity, prevent counterfeiting, and enable targeted recalls.

2. Is serialization mandatory in Saudi Arabia?

Yes. All pharmaceutical products distributed in Saudi Arabia must carry a GS1-compliant 2D DataMatrix barcode containing GTIN, serial number, batch, and expiration date. Serialization is a prerequisite for market access.

3. Is aggregation required under SFDA RSD?

Yes. Aggregation became mandatory in August 2020. Parent-child relationships must be established between cartons, cases, and pallets using SSCC identifiers.

4. Who must comply with Saudi pharma traceability requirements?

Manufacturers, importers, wholesalers, distributors, pharmacies, and hospitals handling pharmaceutical products in Saudi Arabia must comply with SFDA RSD requirements.

5. What barcode format does Saudi Arabia require?

Saudi Arabia requires a GS1-compliant 2D DataMatrix (ECC 200) barcode meeting ISO/IEC 15415 Grade C minimum quality standards.

6. When did Saudi Arabia implement pharma serialization?

Saudi Arabia began its serialization rollout in 2017, with full enforcement completed by 2020. Aggregation became mandatory in August 2020.

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