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Published online: 6 November 2015
© Springer International Publishing Switzerland 2015
Abstract
Objective This study compares the current regulatory review process and good review practices at the Saudi Food and Drug Authority (SFDA) with those of regulatory agencies in Australia, Canada, and Singapore and identifies opportunities for developing the SFDA as a Regional Centre of Excellence.
Methods A questionnaire completed by the SFDA included data regarding the organisation, key milestones, review timelines, and good review practices of the agency. Similar information was obtained within the same timeframe (2014/2015) through the same standard questionnaire regarding the processes and practices for Health Canada, Singapore's Health Sciences Authority, and Australia's Therapeutic Goods Administration.
Results All four regulatory agencies have established target times for scientific assessment and regulatory review, examine dossier sections in parallel, and separate company response time from overall timing. Additionally, all four agencies have instituted good review practices including standard operating procedures, templates, dossier monitoring, and continuous improvement processes, and assign a high priority to transparency in their relationships with the public, healthcare professionals and industry. Of the four agencies, however, only the SFDA requires a Certificate of Pharmaceutical Product (CPP) at the time of the submission and pricing negotiations before final product approval.
Conclusions To assist the SFDA in its efforts to become a Regional Centre of Excellence, it is suggested that the agency explore a risk stratification approach to select dossiers for verification, abridged, or full reviews; use forms of certification other than the CPP; make pricing negotiations independent to the review process; and introduce a feedback process for the quality of the dossier.
1 Introduction
Pharmaceutical regulatory authorities are challenged in their mandate to perform a transparent, timely review of pharmaceutical products for quality, safety, and efficacy. Their performance against that challenge should be regularly assessed against established international qualitative and quantitative benchmarks and identified best practices and procedures to allowagencies to evaluate theirown performance, to provide a baseline against which the impact of change can be measured and to develop realistic improvement initiatives to ultimately ensure that patients in their jurisdictions have expeditious access to innovative, safe, and effective medicines.
In 2015, Alsager et al. [1] conducted a review of the performance of the Saudi Food and Drug Authority (SFDA)...