Abstract
Objective
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.
Methods
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.
Results
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.
Conclusion
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.
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Acknowledgments
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.
Disclosures
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.
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Alsager, S., Hashan, H. & Walker, S. The Saudi Food and Drug Authority: Shaping the Regulatory Environment in the Gulf Region. Pharm Med 29, 93–103 (2015). https://doi.org/10.1007/s40290-015-0089-3
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DOI: https://doi.org/10.1007/s40290-015-0089-3