Saudi Arabia’s SFDA issues draft framework on real-world data and evidence for regulatory use 

The Saudi Food and Drug Authority (SFDA) has published a draft guideline on the use of real-world data (RWD) and real-world evidence (RWE) in medicines marketing authorizations. The document, now open for stakeholder feedback, aims to improve regulatory decision-making in line with Saudi Vision 2030 by defining key concepts, outlining quality standards, and expanding potential applications. 

As the use of RWE for regulatory decision-making grows internationally and expectations for evidence diversity increase, the SFDA aims to ensure that the Kingdom’s regulatory processes remain globally competitive, scientifically robust, and responsive to innovation. Issued on June 22, 2025, the draft framework sets out the SFDA’s proposed approach for integrating RWD and RWE into the regulatory evaluation of medicinal products. It outlines definitions, identifies acceptable data sources and study designs, and details how these evidence types could support decision-making on safety and effectiveness. The authority describes the initiative as part of a wider effort to strengthen the “utilization, appropriateness and quality” of such data in the Kingdom. 

According to the SFDA:  

“advances in data science and medical health records systems can significantly contribute to achieving transformation of health care services and regulations in line with the SFDA fourth strategic objectives and ultimately the Saudi Vision 2030.”  

Dr Sara Al Dallal (President of the Emirates Health Economics Society) described the move as, “a major step toward smarter, more adaptive health regulation in the Kingdom.” 

Study designs and data sources 

The SFDA highlights a range of appropriate RWD sources, including electronic health records (EHRs), medical claims data, patient and disease registries, wearable devices, and patient-reported outcomes. Supported study designs include observational studies, target trial emulation, hybrid trials, pragmatic trials, and registry-based trials. 

Observational studies are noted for their high applicability to clinical practice, though they are, “highly susceptible to bias and confounding.” Hybrid trials combine conventional trial methods with RWD collection, while pragmatic trials assess interventions in routine clinical settings to improve generalizability. Registry-based trials can offer long-term data but require careful attention to harmonization and data quality. 

Data quality, bias, and standardization 

The draft emphasizes that data quality is, “a key element for optimizing the utilization of RWE in regulatory decision-making.” High-quality data should be relevant, complete, coherent, and up-to-date. The SFDA notes that using common data models (CDMs) can enhance accuracy, consistency, and comparability across datasets. 

Bias and confounding are identified as significant challenges, particularly in observational studies. The framework outlines mitigation strategies such as stratification, regression models, propensity scores, and high-dimensional propensity score methods. Target trial emulation and patient matching are also recommended to strengthen causal inferences. 

Potential regulatory uses 

The SFDA proposes multiple applications for RWD and RWE in regulatory settings: 

• Hypothesis generation: supporting drug discovery, repurposing, and early comparisons of treatment strategies. 

• Augmenting single-arm studies: using external or historical controls, particularly in rare diseases or orphan drug development. 

• Transportability and local data: applying local RWD to adapt findings from multi-regional trials to the Saudi population. 

• Informing prior assumptions: contributing to Bayesian statistical models to optimize study design. 

• Addressing under-represented populations: including broader and more diverse groups than typically seen in randomized controlled trials. 

Next steps for stakeholders 

Stakeholders are invited to review the draft framework and provide feedback via the SFDA website. The authority stated that the initiative is: 

“part of a continuous effort to further guide in establishing an understanding of the utilization, potential uses, and optimize the evaluation of such data with the consideration of making future regulatory decisions.” 

If implemented, the framework is expected to play a key role in embedding RWD and RWE within Saudi Arabia’s regulatory processes, supporting national objectives to modernize healthcare and encourage innovation.