Acknowledgement: Prof David Hutchinson; www.canarybooks.com
On 7 August 2015, the Saudi Food and Drug Authority (SFDA) issued ‘Regulations & Requirements for Conducting Clinical Trials on Drugs’. The guidance – which
takes immediate effect – notes that all clinical trials involving drugs must be registered with the SFDA Drug Sector’s Clinical Trials Department by the researcher, sponsor or contract research organisation through the Saudi Clinical Trials Registry. Phases II and III trials require approval from the SFDA, Phase IV trials only require approval from an institutional review board.
On 7 August 2015, the Saudi Food and Drug Authority (SFDA) issued ‘Regulations & Requirements for Conducting Clinical Trials on Drugs’. The guidance – which
takes immediate effect – notes that all clinical trials involving drugs must be registered with the SFDA Drug Sector’s Clinical Trials Department by the researcher, sponsor or contract research organisation through the Saudi Clinical Trials Registry. Phases II and III trials require approval from the SFDA, Phase IV trials only require approval from an institutional review board.
The guidance also covers the requirements for clinical trial amendments, transporting biological samples and investigator qualifications.
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