Pharmaceutical Medicine

, Volume 29, Issue 2, pp 93–103 | Cite as

The Saudi Food and Drug Authority: Shaping the Regulatory Environment in the Gulf Region

  • Sami Alsager
  • Hajed Hashan
  • Stuart Walker
Original Research Article



This study sought to assess the current regulatory review process in Saudi Arabia, identify the key milestones, evaluate the measures used for Good Review Practices (GRevP) and to suggest opportunities for an enhanced regulatory review of medicines.


A questionnaire completed by the Saudi Food and Drug Authority (SFDA) was divided into three parts: Organisation of the Agency, Key Milestones and Timelines and GRevP.


Currently the SFDA carries out a full assessment for the review of all major applications, although they currently lack the expertise to evaluate the preclinical portion of the product file. A Certificate of Pharmaceutical Product (CPP) is required at the time of registration and a pricing agreement internally must be developed before authorisation. Applications may have to wait 2–6 months before review, although priority products are taken out of the queuing system. The median review times for new active substances from submission to approval were 340 working days (2011) and 372 working days (2013); however, the target time was 290 working days. Standard operating procedures (SOPs), review templates and an electronic submission tracking system are in place, but the GRevP framework is still evolving.


Based on the available resources and capabilities, the SFDA is unable currently to meet its overall target timelines, partly due to the sponsor’s time in responding to agency questions. Therefore, it either needs to increase its resources or to implement a risk stratification system based on the Singapore model, which takes into account reviews by reference agencies. The SFDA is encouraged to develop GRevP guidelines to ensure the quality of the review.


Target Time Gulf Cooperation Council Reference Agency Approval Time Pharmaceutical Regulation 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



The authors acknowledge the assistance of Prisha Patel, MSc and Magda Bujar, MSc for the collection and analysis of data and of Patricia Connelly, ELS for editorial support in the preparation of this manuscript. Also, the authors acknowledge the assistance of Abdulmohsen Bahelawa, MSc and Fahad Alqahtani, MSc in the statistical analysis.


This independent research study was conducted by the Centre for Innovation in Regulatory Science (CIRS) as part of its ongoing initiatives to understand pharmaceutical development and regulatory activities in the emerging markets. Support for this analysis was funded in part by a grant from the Pharmaceutical Research and Manufacturers of America (PhRMA).

Sami Alsagar is employed by the Saudi Food and Drug Authority.

Hajed Hashan is employed by the Saudi Food and Drug Authority.

Stuart Walker is the founder of CIRS, London, UK, which conducted the research described in this report.


  1. 1.
    Tufts Center for the Study of Drug Development. Costs to develop and win marketing approval for a new drug is $2.6 billion News release, November 18. 2014. Accessed 17 Dec 2014.
  2. 2.
    Al-Essa R, Salek S, Walker S. An appraisal of good regulatory review practices in the Gulf Cooperation Council States. Drug Info J. 2012;46:57.Google Scholar
  3. 3.
    Salek S, Mallia-Milanes A, McAuslane N, Walker S. Development and application of Scorecards to assess the quality of a regulatory submission and its review. Drug Info J. 2012;46:73.Google Scholar
  4. 4.
    World Health Organization. Good review practice guidelines for regulatory authorities (draft for comment). 2014. Accessed 17 Dec 2014.
  5. 5.
    Liberti L, McAuslane N, Patel P, Breckenridge A, Eichler HG, Peterson R. Regulatory review: how do agencies ensure the quality of decision making? Clin Pharmacol Ther. 2013;94:305–8.CrossRefPubMedGoogle Scholar
  6. 6.
    The Saudi economy in figures. 2013. Accessed 17 Dec 2014.
  7. 7.
  8. 8.
    Bawazir SA. Saudi Food and Drug Authority. Saudi Arabia pharmaceutical country profile; 2012. Accessed 17 Dec 2014.
  9. 9.
    The Cooperation Council for the Arab States of the Gulf. Accessed 17 Dec 2014.
  10. 10.
    Hashan H. Evaluation of the review process for marketing pharmaceutical products in the Gulf States and its impact on patients’ access to medicines. Doctor of Philosophy thesis, 2005. The Welsh School of Pharmacy, University of Wales.Google Scholar
  11. 11.
    McAuslane N, Cone M, Collins J, Walker S. Emerging markets and emerging agencies: a comparative study of how key regulatory agencies in Asia, Latin America, the Middle East and Africa are developing regulatory processes and review models for new medicinal products. Drug Info J. 2009;43:349–59.Google Scholar
  12. 12.
    Walker S, McAuslane N, Liberti L, Leong J, Salek S. A universal framework for the benefit-risk assessment of medicines—is this the way forward? Ther Inn Reg Sci. 2015;49:17–25.Google Scholar

Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  1. 1.Saudi Food and Drug AuthorityRiyadhSaudi Arabia
  2. 2.Centre for Innovation in Regulatory ScienceLondonUK
  3. 3.Pharmaceutical Medicine, School of Pharmacy and Pharmaceutical SciencesCardiff UniversityCardiffWales

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