Procedures and Controls for Conducting Clinical Studies on Medicines

Clinical Studies on Medicines in Saudi Arabia: Key Procedures and Requirements

This document provides detailed guidance for conducting clinical studies on medicines in Saudi Arabia, with a focus on regulatory compliance, safety assessments, and ethical conduct.

Scope and Objectives

The document outlines the objectives, design, methodology, statistical considerations, and organizational mechanisms required for clinical trials, ensuring compliance with international and local standards.

Key Requirements for Clinical Trials

• Approval and Registration
  • Approval and registration with the Saudi Food and Drug Authority (SFDA).
  • Submission of an Arabic-Headed Letter to the SFDA Drug Clinical Trials Department.
• Documentation
  • Institutional Review Board (IRB) Approval.
  • Informed Consent Form.
  • Trial Protocols and Statistical Analysis Plan.
  • Investigator Brochure and Investigational Medicinal Product Dossier.
• Good Clinical Practice (GCP)
  • Adherence to GCP guidelines to ensure ethical and quality standards in clinical research.
• Reporting Requirements
  • Submission of periodic safety reports.
  • Annual Drug Safety Update Report (DSUR) as per the ICH-F2E guideline.
• Investigator and Team Compliance
  • Ensuring all investigators and team members meet certification and training standards.
  • Insurance coverage for the study.

Post-Trial Obligations

• Completion, Suspension, or Termination
  • Notify the local ethics authority when a study is completed, stopped, or suspended.
  • Submit a final report within 60 days of study completion.
• Temporary Suspension
  • If suspension is lifted, the study can either continue or terminate based on the Authority's decision.
• Compliance and Documentation
  • Ensure adherence to guidelines and provide the required documentation for the Authority's review.

These guidelines aim to maintain the highest standards of safety, compliance, and ethical conduct in clinical research, ensuring the protection of participants and the integrity of results.

Source: https://www.sfda.gov.sa/sites/default/files/2025-01/ConductingClinicalTrialsDrugA.pdf
Region: Saudi Arabia