Ensuring SFDA Compliance Across a Large Product Portfolio
Customer Requirement
A pharmaceutical company required preparation of the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) for a large portfolio of products intended for submission to the Saudi Food and Drug Authority (SFDA). The scope included more than 90 drug products, with documentation required in both English and Arabic.
The client needed assurance that all labelling documents would fully comply with SFDA regulatory standards while maintaining consistency, accuracy, and clarity across a diverse range of products. Given the scale of the portfolio, the client sought regulatory affairs consulting expertise capable of supporting high-volume submissions without compromising compliance or submission timelines.
Problem Statement
The client faced several challenges associated with large-scale SFDA labelling preparation:
- Managing SmPC and PIL development for over 90 products simultaneously
- Ensuring strict adherence to SFDA labelling requirements across all documents
- Maintaining consistency in technical content across multiple product lines
- Addressing bilingual (English and Arabic) labelling requirements
- Risk of delays or regulatory queries due to inconsistencies or non-compliance
Without experienced regulatory oversight, the client risked submission delays, increased rework, and potential regulatory objections.
Key Objective
To prepare accurate, SFDA-compliant SmPCs and PILs (English and Arabic) for a large product portfolio, enabling timely submissions while ensuring regulatory consistency and confidence across all products.
DDReg Regulatory Support & Outcome
DDReg supported the client by providing regulatory oversight and execution for SmPC and PIL development aligned with SFDA expectations. The engagement focused on ensuring that all documents met local regulatory requirements, reflected approved Saudi labelling standards, and remained consistent across the entire portfolio.
The SmPCs and PILs were developed to meet SFDA requirements for content, structure, and clarity, supporting regulatory acceptance and submission readiness without exposing the client to compliance risk.
Business Impact
Through DDReg’s regulatory support:
- SmPCs and PILs for over 90 products were successfully prepared in compliance with SFDA standards
- English and Arabic labelling requirements were met consistently across the portfolio
- Submission timelines were maintained despite the scale and complexity of the project
- Regulatory risk associated with high-volume labelling preparation was minimized
- The client gained confidence in managing large-scale SFDA submissions
Key Learning
High-volume regulatory labelling projects require not only technical accuracy but also strong regulatory judgment and consistency. Expert oversight enables efficient preparation of compliant SmPCs and PILs across diverse portfolios, supporting timely market access in highly regulated markets such as Saudi Arabia.
DDReg supports SFDA submissions through compliant SmPC and PIL authoring for single products and large portfolios, ensuring regulatory alignment, bilingual labelling accuracy, and efficient market entry.
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