title: The Saudi Arabia Food and Drug Authority: An Evaluation of the Registration Process and Good Review Practices in Saudi Arabia in Comparison with Australia, Canada and Singapore.
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.
authors.affiliation: Licensing Department, Saudi Food and Drug Authority, North Ring Road, Al Nafal Unit (1), Riyadh, 13312-6288 Saudi Arabia.
authors.forename: Hajed
authors.initials: H
authors.lastname: Hashan
authors.affiliation: Saudi Food and Drug Authority, North Ring Road, Al Nafal Unit (1), Riyadh, 13312-6288 Saudi Arabia ; Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Aljuffali
authors.affiliation: Global Development Programme, Centre for Innovation in Regulatory Science, 77 Hatton Garden, London, EC1N 8JS UK.
authors.forename: Prisha
authors.initials: P
authors.lastname: Patel
authors.affiliation: Centre for Innovation in Regulatory Science, 77 Hatton Garden, London, EC1N 8JS UK ; School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Cardiff, Wales.
authors.forename: Stuart
authors.initials: S
authors.lastname: Walker
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