Saudi FDA Requires Registration of Clinical Trials
All sponsors planning to conduct clinical trials in Saudi Arabia for the first time must register their studies through the Saudi Clinical Trials Registry, under new guidance released Sunday.
Phase 2 and 3 trials also require approval from the Saudi Food and Drug Administration, which carries a $4,000 evaluation fee. For Phase 4 trials, only the approval of an institutional review board is required. Phase 1 trials just require registration.
Companies must submit a yearly progress report on ongoing trials and inform the SFDA within 60 days of completing, terminating or suspending a trial, followed by a final report within 12 months. Trial-related adverse reactions must be reported within 15 days if they are serious and within seven days if they are fatal or life-threatening.
The guidance also covers requirements for exporting biological samples from trial participants and investigator qualifications.
Read the guidance here: www.fdanews.com/8-15-SaudiTrials.pdf. — Jonathon Shacat