ArticleTherapeutic innovation & regulatory science2025
Descriptive Analysis of Good Clinical Practice Inspection Findings from the Saudi Food and Drug Authority.
Article in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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6 authors.
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Abstract
introductionThe Saudi Food and Drug Authority (SFDA) conducts inspections in accordance with Good Clinical Practice (GCP) to safeguard clinical trial integrity and protect the rights, safety, and welfare of study participants. These inspections ensure that trials are conducted in compliance with GCP and applicable laws.
objectivesThe study aims to provide a description of GCP inspection findings, analyze their impact on the clinical trial ecosystem, and provide recommendations to improve clinical trial conduction in Saudi Arabia.
methodsA review was conducted on inspection reports, with two senior independent inspectors examining, collecting, and categorizing the data. Descriptive statistics were used to summarize the categorical variable via frequency distributions.
resultsA total of 131 GCP inspections were performed between 2017 and 2023, totaling 722 observations from 116 (88.5%) inspection visits. The remaining 15 (11.5%) inspection visits recorded no observations. The highest number of visits were conducted in contract research organizations (CRO) (n = 50; 38.2%) with 118 observations, followed by clinical investigator sites (n = 46; 35.1%) with 313 observations, then bioequivalence (BE) centers (n = 33; 25.2%) with 256 observations, and the last 2 (1.5%) visits were conducted in phase I clinical trial units with 35 observations.
conclusionThis study assesses GCP inspection reports and examines the types of deficiencies and their grades in each area. Observation categories and grades were found to vary by organization type, which indicates the need for specific action plans addressing each organization type separately. This report provided recommendations based on the most common findings to assist researchers and sponsors when conducting clinical trials in Saudi Arabia.
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