Regulating Clinical Trials in Saudi Arabia
SA. Bawazir, H. Hashan, A. Al Hatareshah, A. Al Ghamdi and K. Al Shahwan
Affiliation: Saudi Food and Drug Authority, 3292 Northren Ring Rd, Riyadh 13312 – 6288, Kingdom of Saudi Arabia.
Keywords: Clinical trials, Saudi Arabia, regulations, registry, SFDA, clinical practice, pharmaceuticals, CRO, IRB, investigator,
inspection, healthcare, Middle East.
The rising needs for new clinical trials in different medicinal fields have paved the area to conduct numbers of clinical trial in Saudi Arabia. The article provides brief description of clinical trial regulations and further explores opportunities for development. The clinical trial administration was established in 2009 and is responsible for assessing all clinical trial applications from sponsors, Clinical Research Organizations and investigators to conduct clinical trial in Saudi Arabia. The functions of clinical trial administration include evaluation of clinical trial protocols and amendments, good clinical practice (GCP) inspection and maintaining Saudi Clinical Trials Registry. The main requirements to license clinical trial in Saudi Arabia include: trial protocol, inform consent form, the site IRB/EC approval to conduct the trial, confidentiality agreement between the sponsor and the principle investigator, investigator brochure, financial disclosure of principal investigator, certificate of analysis of study medicinal product, investigational medicinal product (IMP) labeling & packaging, Clinical trial agreement between the sponsor and the principle investigator and subjects Insurance. The administration had licensed 260 clinical trials to date. The future development of clinical trial environment in Saudi Arabia is promising. The Saudi Food and Drug Authority have created state of the art regulatory framework that support quick approval of clinical trial. Moreover, the presence of numerous world-class medical facilities and increasing numbers of western-trained investigators as well as rapidly growing pharmaceutical market and healthcare investments, contribute to enhancing Saudi Arabia’s attractiveness to conduct more clinical trial within the coming few years to come.
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