2 min read

What is it?

The shift toward digital regulation in Saudi Arabia refers to the integration of online platforms, electronic dossier submission (e CTD), track-and-trace systems, and automated workflows under the Saudi Food & Drug Authority (SFDA). These systems aim to streamline product registration (medicinal products, devices, Cosmetics), improve transparency, enable real-time monitoring, and anchor Regulatory operations in Saudi Vision 2030.

  • Example: The SFDA’s eServices portal lists multiple digital systems for drugs, medical devices, audit, registration, and post-market surveillance.
  • Example: The “Drug Track and Trace System (DTTS)” user manual outlines how each drug unit is tracked via GTIN/GLN and integrated via SFDA’s stakeholder portal.

What Are the Core Components of This Trend?

  1. Unified electronic submission portals – Manufacturers use SFDA’s dedicated platforms (e.g., SADR for drugs; GHAD for medical devices) to submit applications online.
  2. Track-and-trace and serialization – Systems like DTTS ensure each unit of registered human drugs is traceable from import/manufacture to dispensing.
  3. Streamlined dossier requirements – New guidance (2025) indicates optionality of CPP/Free Sale Certificates at submission, reducing administrative burden.
  4. Data-driven Regulatory workflows – Platforms integrate Regulatory intelligence, application status tracking, fee payment and query management for more predictable outcomes.

What Are the Driving Forces Behind This Digital Shift?

  • Vision 2030 goals: Saudi Arabia’s national vision emphasises digital transformation of government services, including regulatory-health frameworks.
  • Efficiency & backlog reduction: Online systems help reduce manual review cycles, paperwork delays, and enhance throughput of marketing-authorisation applications.
  • Global standard alignment: With international regulators embracing eCTD, SFDA’s digital adoption helps harmonise dossier formats and expedite reliance/regulatory-convergence pathways.
  • Supply-chain transparency & patient-safety: Tracking systems and real-time data contribute to authenticity, anti-counterfeiting efforts and post-market surveillance capabilities.

What Are the Technical & Practical Implications for Manufacturers?

  • You must create an account and register your establishment and product via SFDA’s electronic portals (e.g., SADR, GHAD).
  • Your CTD/eCTD dossier must align with SFDA’s digital validation criteria and local Module 1 content: incomplete or mis-formatted submissions risk delay.
  • Serialization and traceability obligations apply under systems like DTTS: each unit must carry a GTIN/serial and be traceable via the stakeholder portal.
  • Query management and application status tracking are integrated into SFDA’s e-platforms monitoring submission progress and aligning internal Regulatory timelines is key.
  • Regulatory fees, correspondence, renewals, and post-market activities are increasingly managed via the same electronic ecosystem.

What Are the Challenges of this Digital Shift?

  • Legacy submission inertia: Transitioning from paper or non-standard formats to fully eCTD/digital workflows demands investment in internal systems, training, and Regulatory-affairs infrastructure.
  • Portal integration & data quality: Electronic systems are only as effective as the data they hold—poor data formatting, missing modules, or mis-tagged files can result in delays.
  • Interoperability with legacy/regional systems: While SFDA’s portals are advancing, integrating with cross-border/regional Regulatory systems or legacy databases may pose complexity.
  • Change-management for local stakeholders: Local agents, MAHs, and manufacturers must adapt to new workflows, dashboards, and digital submission cycles.
  • Compliance-readiness around serialization/traceability: Meeting GTIN/GLN requirements, render-by/expiry tracking, and supply-chain visibility can be operationally intensive.

What Are the Emerging Trends You Should Watch?

  • Full adoption of eCTD (sequence submissions, lifecycle uploads) across medicinal products, enabling versions and amendments to be managed digitally.
  • Increased use of reliance/accelerated pathways facilitated by digital dossiers and regulatory-intelligence interoperability.
  • Blockchain/advanced traceability tools within SFDA-track systems, enhancing anti-counterfeiting and supply-chain transparency.
  • AI‐/ML-enabled review tools where SFDA may deploy automated checks on dossier completeness, labeling compliance, or adverse‐event signals.
  • Regional Regulatory ecosystems linked electronically, Saudi systems may increasingly interface with GCC Regulatory platforms and harmonised databases.

Want to leverage this digital Regulatory transformation in Saudi Arabia and optimise your submission strategy?

Contact our Regulatory digital experts to align your CTD/eCTD workflows with SFDA’s digital criteria and accelerate your market access journey.