Pharmaceutical Serialization in the GCC: Progress, Challenges, and Future Directions

Pharmaceutical serialization, a cornerstone of supply chain security, is rapidly advancing across the Gulf Cooperation Council (GCC) countries. This strategic approach ensures the traceability of medications and combats counterfeiting, safeguarding both healthcare systems and patients. Below is an in-depth exploration of the status and ongoing initiatives in key GCC nations:

#Saudi Arabia

The Saudi Food and Drug Authority (SFDA) is a regional leader in serialization, implementing stringent traceability measures to enhance the integrity of its pharmaceutical supply chain.

Milestones Achieved:

• Since 2018, serialization requirements have extended from manufacturers to include distributors, pharmacies, and hospitals. The SFDA enforces the use of GS1 standards for encoding product details such as the Global Trade Item Number (GTIN), batch number, and expiry date.
• In 2019, aggregation became mandatory, allowing individual product identifiers to be linked to larger packaging units, such as cartons and pallets.
• These efforts align with Saudi Arabia's Vision 2030, aiming to modernize its healthcare infrastructure and ensure secure medication access.

Impact:

Saudi Arabia’s approach has set a benchmark in the region, reducing counterfeit medications and streamlining regulatory compliance across the supply chain.

#United Arab Emirates (UAE)

The UAE has made significant strides with its "Tatmeen" system, a robust track-and-trace platform ensuring pharmaceutical safety and integrity.

Serialization Framework:

As of December 13, 2022, serialization is compulsory for secondary packaging, which must display:

• GTIN
• Randomized serial number
• Batch/lot number
• Expiry date

Aggregation requirements extend to the assignment of Serial Shipping Container Codes (SSCC) across packaging levels.

Exemptions and Focus:

While serialization applies broadly, certain products, including General Sales List medications and medical devices, are excluded from the requirements.

Vision:

Tatmeen aims to position the UAE as a global leader in pharmaceutical security by leveraging technology to ensure transparency and trust throughout the supply chain.

#Bahrain

Bahrain's National Health Regulatory Authority (NHRA) has adopted a phased approach to serialization, enabling a gradual yet comprehensive rollout:

1. Phase 1: By the end of 2021, Marketing Authorization Holders (MAHs) were required to serialize their products and report data to the NHRA’s MVC Hub using EPCIS protocols.
2. Phase 2: Aggregation of products into cases and pallets was mandated starting in May 2022.
3. Phase 3: By June 2022, customs, agents, pharmacies, and other stakeholders were required to authenticate medicines through barcode scanning.

Compliance Standards:

The NHRA enforces the use of GS1 DataMatrix barcodes, embedding product details such as GTIN, batch number, expiry date, and serial numbers.

#Kuwait

While Kuwait is in the preparatory stages, its Ministry of Health (MoH) has charted a clear path toward serialization.

Upcoming Mandates:

Starting January 2024, all pharmaceuticals must feature GS1 DataMatrix barcodes with four key data elements: GTIN, batch number, expiry date, and serial number.

Challenges and Discussions:

Current efforts focus on barcoding, with traceability reporting and aggregation frameworks under development. Stakeholders continue to engage in dialogue to establish robust systems.

#Oman and Qatar

Both Oman and Qatar are in the nascent stages of serialization implementation:

• Oman: Serialization is required, but the country has yet to establish a system for traceability reporting.
• Qatar: Serialization efforts are focused on barcoding, with future plans to introduce full-scale traceability solutions.

Regional Harmonization and Collaborative Efforts

The Gulf Health Council (GHC) is spearheading initiatives to align serialization efforts across the GCC.

Standardization:

In September 2023, the GHC introduced unified barcoding requirements to harmonize compliance across member states, ensuring consistency in traceability standards.

Innovative Projects:

The GHC's Electronic Patient Information Leaflet (e-PIL) initiative aims to provide digital access to harmonized, up-to-date information on pharmaceuticals, promoting patient safety and transparency.

Key Takeaways

• Progressive Adoption: Countries like Saudi Arabia and the UAE are leading the charge with mature serialization and traceability frameworks, while others are gradually building their capabilities.
• Unified Vision: Regional harmonization by the GHC reflects a collective commitment to secure and transparent pharmaceutical supply chains.
• Challenges Ahead: Achieving full compliance across the GCC requires addressing technological disparities, resource constraints, and the complexities of aggregation and reporting.

Serialization in the GCC not only protects against counterfeit drugs but also strengthens the region's healthcare ecosystem, ensuring trust and safety for millions of patients. As these initiatives mature, the GCC stands poised to set a global standard in pharmaceutical traceability.