On 7 September 2025, the Saudi Food and Drug Authority (SFDA) issued its first official guideline on Good Review Practices (GRevPs) for human medicinal product applications. This document, developed in alignment with international regulatory best practices (WHO, FDA, IMDRF), aims to enhance the quality, consistency, and transparency of regulatory reviews in Saudi Arabia.
Objective of the Guideline
The guideline provides structured principles and processes for the review of safety, efficacy, and quality data in drug applications, including:
New applications Variations of existing authorizations Renewals Its primary goal is to promote evidence-based, efficient, and transparent decision-making while ensuring alignment with global regulatory standards.
Key Features of GRevPs
Evidence-based reviews: Decisions anchored in scientific integrity and international regulatory frameworks. Standardization: Use of SOPs, checklists, and templates to ensure consistency. Continuous improvement: Regular updates based on evolving science, regulatory changes, and stakeholder feedback. Reviewer competency: Ongoing training and capacity building to ensure technical and scientific expertise.
Ten Principles of a Good Review
Balanced – impartial and unbiased assessments Contextualized – consideration of intended use and external regulatory decisions Evidence-based – integration of scientific and regulatory requirements Signal identification – early detection of concerns Problem-solving – applying regulatory flexibility and risk-based approaches Integrated – linking preclinical, clinical, manufacturing, and risk management data Thorough – comprehensive follow-up on all relevant issues Critical analyses – robust evaluation of data integrity and labeling Well-documented – clear, defensible reports supporting decisions Well-managed – structured processes with defined timelines and quality controls These principles ensure predictability, efficiency, and transparency throughout the review lifecycle.
Review Process and Pathways
The SFDA review framework includes two main stages:
Validation review – verifying application completeness and compliance with format requirements. Scientific review – assessing safety, efficacy, and quality data, using Regular, Priority, or Reliance pathways (Verification/Abridged). Final decisions are based on multi-disciplinary assessments, with provisions for expert consultation and advisory committee input in complex cases.
Transparency and Stakeholder Engagement
Publishing Saudi Public Assessment Reports (Saudi-PARs) with redacted confidential data. Making SPCs and PILs available in Arabic and English through the Saudi Drug Information System (SDI). Issuing regular safety updates, risk management measures, and electronic bulletins. Engaging with applicants, industry associations, and external experts through consultations and feedback mechanisms.
Implications for Industry
Greater predictability in review timelines and expectations More structured communication channels with regulators Enhanced alignment with international best practices Opportunities to improve dossier quality and reduce review cycles
References
World Health Organization, Technical Report Series No. 992, Annex 9 (2015) U.S. FDA, Good Review Management Principles and Practices, Draft Guidance (2018) IMDRF, Good Regulatory Review Practices (2017) WHO, Good Reliance Practices in Regulatory Decision-Making (2020)
