Quality challenges in herbal product registration: Evidence from a five-year Saudi Arabian experience

The assurance of safety and quality in herbal products is a principal mandate of regulatory authorities. The Saudi Food and Drug Authority (SFDA) mandates the pre-marketing evaluation of herbal products, focusing on the active pharmaceutical ingredient (API) and finished pharmaceutical product (FPP) components [ 1 ] [ 2 ]. This study aims to identify common quality issues observed during the initial evaluation of herbal products, with the objective of enhancing regulatory compliance and procedural efficiency. A retrospective observational analysis was conducted on herbal product applications submitted to the SFDA between 2019 and 2023. SFDA’s internal quality evaluation reports and application data from SFDA systems were utilized. Only applications classified as herbal products were included. Descriptive statistical analyses were performed using SPSS version 26.0. A total of 308 applications were analyzed. Analysis of the API evaluation revealed that 69% of quality issues were related to product specifications, primarily concerning residual solvents and assay methodology. Additional issues were associated with batch analyses and manufacturing process descriptions. In the FPP evaluation, the highest frequency of quality issues was observed in the Batch Formula and Specifications sections, particularly regarding the completeness of assay data. Furthermore, frequent deficiencies were noted in the labeling of storage conditions and the submission of alcohol-free and pork-free certifications.The quality issues identified during the pre-marketing evaluation of herbal product applications represent a major factor contributing to prolonged registration timelines. To address these challenges, it is recommended that SFDA develop targeted and illustrative guidelines for manufacturers, thereby facilitating timely market access while ensuring the maintenance of rigorous quality standards. Publication History Article published online: 05 March 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany