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
Submitted: 25 September 2023; Revised: 17 October 2023; Accepted: 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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