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Regulations & Requirements for Conducting Clinical Trials – SFDA

Saudi Food & Drug Authority released updated guidance on Regulations and Requirements for Conducting Clinical Trials in regards to “Early phases trials and Completion, Termination, or Suspension of Clinical Trials”

According to the Saudi Food and Drug Authority law all clinical studies should be registered at SFDA through the Saudi Clinical Trial Registry system (SCTR), Knowing that the registration of a clinical trial (registering the trial in the system) does not mean the approval of the trial.

For more information about the registration process, you can check the registration guideline through this link.

The following regulations, memos, and guidelines must be obligated:

§ Guideline for Good Clinical Practice.

§ Law of ethics of research on living creatures and its implemented regulation, which was issued on 14/9/1431 H by Royal decree number (M/59).

§ The memo number (15421) and (15482) dated on 13/5/1434H in regard to the registration of local institutional review boards (IRBs).

To get more details on this guideline click this LINK


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