Strengthening Regulatory Compliance in Saudi Arabia: SFDA Issues Updated Guidelines on Drug Submission and Review Practices

The Saudi Food and Drug Authority (SFDA) has recently published two major regulatory documents that reinforce its commitment to transparency, efficiency, and international harmonization in the evaluation of medicinal products:

• Human Drug Submission Guideline (Version 4)
• Good Review Practices (GRevPs) Guideline Together, these guidelines establish a structured framework for both industry submissions and regulatory reviews, ensuring that decisions on safety, efficacy, and quality are consistent, evidence-based, and aligned with global best practices.

Human Drug Submission Guideline (V.4)

Released as an updated reference for applicants, Version 4 …

• New marketing applications
• Variations and renewals
• Post-marketing commitments

Key Highlights

• Electronic Submissions: Dossiers must be submitted in eCTD or NeeS format in line with SFDA’s technical specifications.
• CTD Structure: Applications must follow the ICH Common Technical Document (CTD) format, covering administrative, quality, non-clinical, and clinical modules.
• Good Submission Practices (GSPs): Applicants are expected to provide complete, accurate, and well-structured submissions. Use of SFDA templates and checklists is
  strongly recommended to avoid delays.
• Pathways: Applications may follow regular, priority, or reliance (verification/abridged) pathways, depending on product type and public health needs.

Good Review Practices (GRevPs)

Complementing submission requirements, the SFDA also issued its first formal Good Review Practices (GRevPs) Guideline…

Objectives

• Ensure reviews are evidence-based, well-documented, and impartial
• Standardized processes across SFDA departments through SOPs, templates, and checklists
• Strengthening reviewer competencies via structured training and continuous development
• Promote transparency through publication of assessment reports (Saudi-PARs) and safety updates

Implications for Regulatory Professionals

For regulatory affairs teams and pharmaceutical companies, these guidelines represent a dual framework for compliance:

1. Submission Excellence – delivering high-quality dossiers that meet SFDA’s updated requirements.
2. Review Preparedness – understanding how SFDA reviewers assess applications…

Conclusion

The release of the Human Drug Submission Guideline (V.4) and the Good Review Practices Guideline mark an important milestone …