Preclinical and Clinical Trial Requirements: Saudi Arabia
STA / Saudi Arabia
All legal aspects surrounding preclinical and clinical trial requirements in Saudi Arabia. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: Saudi Arabia, available to purchase here for GBP 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
It is mandatory to inform SFDA immediately about any Suspected Unexpected Serious Adverse Reactions (SUSAR) as soon as possible, no later than 15 days. If the SUSAR is fatal or life-threatening, SFDA must be informed as soon as possible, no later than seven days following (ICH-E2A) guideline.
2. How are clinical trials funded?
A total of 80 sponsors funded the clinical studies in Saudi Arabia. The majority of the clinical trials are funded by multinational pharmaceutical companies. Oncology (13.81%) and diabetes (11.71%) were the most common therapeutic areas and constituted the largest proportion of the overall studies.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
“The Saudi Food and Drug Authority” have created a state of the artstate-of-the-art regulatory framework that supports quick approval of clinical trials. Saudi Clinical Trials Registry (SCTR) is an online record system for the registration of clinical trials being conducted in Saudi Arabia. The requirements for the clinical and pre-clinical trial are:
- Headed Letter to SFDA
- SCTR registration
- Bank Transfer Payment (for non-governmental)
- Confidentiality Agreement
- Trial Protocol
- Informed Consent Form
- IRB/EC Approval
- Investigator Brochure (include preclinical data)
- Financial Disclosure of Principal Investigator
- GMP Certificate
- Certificate of Analysis of Study Drug
- Labelling of Study Drug
- Clinical Trial Agreement
- CVs of Principal Investigator & Coordinator
- Case Report Form
- Subjects Insurance
- Delegation/Authorization Letter (for CRO)
4. What are the requirements for consent by participants in clinical trials?
Informed consent is a process by which the participant voluntarily confirms his/her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the participant’s decision to participate in a clinical trial. Informed consent has the potential as a risk management activity to ensure that patients have been provided with adequate information concerning the study as well as the risks of the medicine and appropriate Clinical Trial Authorization Process.
5. May participants in clinical trials be compensated?
Participants in clinical trials did not receive any compensation.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
N/A
