Early Scientific Advice for Health Technology Assessment: Progressing Towards a Framework in Saudi Arabia

Background Early Scientific Advice (ESA) is an independent, non-binding process that gives patient-centred scientific guidance to manufacturers in the pre-market stage of product development. Unlike advisory boards, ESA provides objective advice from Health Technology Assessment (HTA) bodies or regulatory authorities, aiming to support the development of healthcare technologies in line with regulatory and health policy goals. This study examines global ESA practices and suggests a framework for implementing ESA in Saudi Arabia. Methods A literature review was conducted to examine established ESA systems, focusing on processes, workflows, timings, challenges, and lessons learned. Additionally, a roundtable discussion with experts from regulatory bodies, healthcare providers, and industry was held to identify the key pillars of the Saudi ESA framework. Several related topics were covered, including governance, patient involvement, types of products, review timing, the distinction between ESA and advisory boards, horizon scanning, and the use of ESA for technical quality assessments. Results The roundtable discussion revealed that the ESA framework in Saudi Arabia should focus on pharmaceuticals as well as medical devices. The panel proposed considering ESA before drug registration in late-stage clinical development and for phase 2 and 3 trials of drugs for diseases with local relevance (e.g., rare diseases). For medical devices, the ESA process should occur post-marketing authorization. It was agreed that the ESA process should be governed by the HTA body. Experts also recommended patient involvement during ESA review using targeted questionnaires to ensure a comprehensive review. Conclusion ESA in Saudi Arabia can enhance stakeholder engagement in the approval and reimbursement processes for pharmaceuticals, diagnostics, and medical devices. Implementing ESA within Saudi Arabia's advanced healthcare system is essential to support manufacturers, optimize outcomes, and improve access to these interventions.