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

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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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