Accelerating Access to High-Quality Generic Medicines in Saudi Arabia through Advanced SFDA Regulatory and CMC Practices
Abstract
Saudi Arabia is aiming to increase the use of generic medicines in order to improve affordability, access to treatment, and pharmaceutical security, but in order to speed up the registration process it is essential to ensure pharmaceutical equivalence, bioequivalence, consistency in manufacturing, and quality throughout the product's lifecycle. This review looks at how the advanced regulations of the Saudi Food and Drug Authority (SFDA) together with its requirements in the areas of chemistry, manufacturing, and controls (CMC) can help to reduce unnecessary delays in both development and review while at the same time maintaining confidence in generic drugs. A structured integrative review was carried out of 30 sources published between 2020 and 2025, these comprising SFDA guidance, WHO and ICH standards, empirical studies conducted in Saudi Arabia and literature on pharmaceutical quality. The evidence was grouped according to the design of the regulatory pathway, CMC development, the equivalence strategy, analytical lifecycle management, inspection, and post-approval access. The Saudi data indicate that there is a well-developed bioequivalence system, but preventable problems are still occurring due to the quality of the study centres, the readiness of the dossier, and fluctuating public confidence. The application of a quality-by-design approach, risk-based control measures, reliable dissolution methods, active-substance master files, stability science, and proactive control of impurities can lead to greater success in the first cycle of review. The review suggests an integrated model that includes obtaining early scientific advice, carrying out product-specific equivalence planning, applying a risk-based review and reliance approach, ensuring high quality in the digital dossier, and carrying out lifecycle surveillance. Regulatory acceleration should therefore be achieved by improving the structure of the evidence rather than by reducing the amount of evidence, thus allowing for faster access to medicines, greater local manufacturing, reliable interchangeability, and increased trust in high-quality generics.