Trends in Saudi FDA drug approvals and GMP inspections: an observational study

Category: Review Article
Visits: 183 total, 3 today
Keywords: Common Technical Documents, drug regulation, good manufacturing practice, Saudi FDA

Author byline as per print journal: Dr Ali M Alhomaidan; Mohammed Abdulaziz Alageel; Turki Abdulaziz Alrafie; Hassan Mohammed Alqarni; Ibraheem Yahya Khbrani; Dalal J Alkhamis; Mohammed F Alkhalifah; Abdualmajeed S bin Jumaiah; Dr Mohammed A Dahhas

The Saudi Food and Drug Authority’s (SFDA) pharmaceutical products approval and regulation procedures have changed and become more sophisticated over the course of the past 10 years. Although medical advances give patients more therapeutic options, issues can arise if the promotion of pharmaceuticals prompts medications that were approved on the basis of limited evidence to be used in patients for whom there is little evidence of benefit or to replace tried-and-true therapies with better-known risks and comparable or superior effectiveness. These flaws in the market can lead to costs that might not be justified by enhanced therapeutic effectiveness because new medicines are sometimes more expensive than the existing forms. As the top regulatory body in the Middle East and North Africa (MENA) region, the SFDA’s long-term objective is to establish itself as a global hub of regulatory excellence and hasten patient access to medications. In this paper, we discuss the most prevalent product review gaps (CTD deficiencies), GMP inspection deficiencies noted, explore the evolution of laws and standards that impact drug regulation, examine the use of new approval programs and standards, delineate the changes in the number of drugs approved from 2011 to 2020, and expand the role and authority of the Saudi FDA.

Submitted: 25 September 2023; Revised: 17 October 2023Accepted: 18 October 2023; Published online first: 18 October 2023


All pharmaceutical goods that are commercially available in Saudi Arabia are required by law to have a marketing authorization. The frequency of new medicine approvals has dramatically increased over the last decade. In Saudi Arabia, 5498 pharmaceutical items were registered in 2011. By 2020, this number rose to 10424. Drug approvals and the variety of active ingredients on which these new medications are based have been steadily rising over time as novel technologies are developed and introduced, regulatory frameworks change, and merger and acquisition activities fuel more consolidation. It is anticipated that these trends will persist over the coming 10 years.

The use of unsafe, adulterated, or ineffective medications can lead to therapeutic failure, disease exacerbation, drug resistance, and occasionally even death. This is why it is necessary to regulate the use of all pharmaceuticals. Additionally, the introduction of any unsafe or ineffective medication erodes trust in healthcare institutions, medical experts, and pharmaceutical producers and suppliers. Neither consumers nor governments should waste money on cheap, inefficient medications. To successfully oversee the production, distribution, and use of medicines in order to safeguard and advance public health, governments must set up powerful national regulatory agencies. The Saudi Food and Drug Authority (SFDA), which was founded under Council of Ministers Resolution No. 1 from 07/01/1424 H, is responsible for assuring the correctness, quality, safety, and efficacy of medicines in Saudi Arabia, as well as the regulation and supervision of manufacturing facilities, importation, and registration of these products.

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