Frequently Asked Questions
1. What are the SFDA Clinical Trial Regulations?
SFDA Clinical Trials Regulations effect in April 2010, is the legal tool that adapted from international Regulatory authority (FDA, EMA and ICH) and the SFDA Clinical trials Regulations have their own regulations in specific scientific and ethical directives according to national law.
2. Are all clinical trials covered by the SFDA Regulations?
The SFDA Regulations cover all investigations/ Non-interventional studies which are undertaken to discover the efficacy or safety of a medicine in human subjects. Non-interventional trials are waived from several directive stated in the Regulations.
3. What waives that SFDA regulation stated regarding Non-interventional trials application?
Beside accelerated evaluation pathway (4 weeks) For such studies the documentation of clinical trial application should submitted with below documents:
1. Headed Cover Letter to VP of drug affaires.
2. Study Protocol.
3. IRB approval.
4. C.V of Investigators.(If applicable).
5. List of names of Investigators and sites that Post Marketing Studies will conducted.
5. Consent form (English & Arabic).
6. CRF.
4. What steps are being taken by SFDA to deal with the concern of the individual researcher , academic institution and non government organization funded clinical trials who fear that the SFDA regulation could unnecessarily delay or stop trials?
As well as submitting a complete Clinical Trial application file and trials involving products with a registered drug that are prescribed in the usual manner and used in accordance with the registration; SFDA response will be accelerated with waives from several directive stated in the Regulations.
5. What are the SFDA Regulations requirements for sponsorship?
The SFDA does require a sponsor to take responsibility for the initiation, management and/or financing of a trial.
6. How are clinical trial volunteers be protected under the Regulations?
The SFDA Regulations require that each trial has a sponsor who must obtain approval from SFDA and approval from ethics committee in clinical trial site before the trial can conduct. additionally, there are a national requirements that must followed according to Issued Royal Decree No. (321) on 9 Ramadan 1431 H and the judge approving the ethics of research on living creatures, prepared by the National Committee for Bioethics and medical King Abdulaziz City for Science and Technology. Finally, a requirement that medicines used in trials are manufactured to standards of Good Clinical Practice (GCP) to prevent subjects being exposed to unsafe medicines.
7. Is GMP certificate is mandatory for all study drugs?
The SFDA Regulations require that medicines to be used in a trial be manufactured to standards of Good Manufacturing Practice (GMP) to prevent participants being exposed to unsafe medicines. GMP certificate is not require for registered drug in SFDA.
8. What is the role of sponsor/investigator regarding Safety?
During the trial the sponsor and investigator monitor participants’ safety and notify SFDA and the ethics committee of any unexpected serious adverse reactions to the medicines used in the trial so that the effects of unanticipated risks are minimized.
9. What's the process should be follow to notify ADR/SE to SFDA?
the sponsor should report ADR to National center of pharmacovigilance and clinical trial department if the drug is registered in SFDA. For unregistered drug in SFDA reporting should sent only to Clinical trial department. The sponsor must reports (written report) the event to SFDA within 7 calendar days If the event is serious, unexpected, drug related and results in the following outcome: Death, life threatening, persistent or significant disability/incapacity, requires or prolongs hospitalization, congenital anomaly/birth defect and important medical event. If the event is serious , unexpected, drug related and: non life-threatening the sponsor submits a written report of the event to the SFDA within 15 calendar days.
10. Are there any fees to conduct a clinical trial? And why?
The SFDA charges fees to recover the administration costs of evaluation, authorization, and inspection. The fees charged is 15.000 SAR for one study.
11. I am an individual researcher without sponsorship. Is it possible to differentiate between commercial and academic research for the purpose of charging fees?
SFDA waives charging fees for individual researcher , academic institution and government organization funded clinical trials.
12. What are the intermediary planning for a trial that began before the Regulations were effected?
All currently conducted clinical trials were converted to “Clinical Trial notification” without any further application. SFDA require only the Preliminary Results , final findings and PSUR.
13. Are there any documents required to conduct study on approved drugs for approved indication but with new dosing regimen.
Yes. For such case interventional studies, the sponsor or researcher should apply for Clinical Trial authorization, the application should include:
ü Headed Letter to SFDA.
ü Bank Transfer Payment. (If applicable, Only for Clinical Trial sponsored by Pharmaceutical Company)
ü Confidentiality Agreement between the sponsor and the Principle Investigator.
ü Trial Application Form.
ü Trial Protocol.
ü Informed Consent Form (English & Arabic)
ü IRB/EC Approval.
ü Investigator Brochure.
ü Financial Disclosure of Principal Investigator.
ü GMP Certificate. (For unregistered drug in SFDA)
ü Certificate of Analysis of Study Drug. (For unregistered drug in SFDA)
ü Label of Trial Drugs.
ü Investigational Medicinal Product (IMP) Labeling & Packaging. (For unregistered drug in SFDA)
ü Clinical Trial Agreement between the sponsor and the Principle Investigator.
ü CVs of Principal Investigator & Sub-investigator.
ü Samples of Trial Drugs (For unregistered drug in SFDA and Registered drug packaged differently from the registration application).
Also, when final findings showed a significant result , the sponsor should apply to register the new dosing regimen in SFDA.
14. Is approval required for approved drugs currently already on the Saudi Market in which the investigator wishes to study this drug for its approved indication in the Saudi population.
Yes. In case of (non-interventional) , the sponsor or researcher should apply for Clinical Trial authorization, but with different requirement .The application should include:
ü Headed Letter to SFDA.
ü Trial Application Form.
ü Trial Protocol.
ü Informed Consent Form (English & Arabic)
ü IRB/EC Approval.
ü Clinical Trial Agreement between the sponsor and the Principle Investigator.
ü List of investigators and sites of trial.
15. Who is responsible for registering the trial?
The sponsor of the clinical trial; - OR - The principal investigator (PI), so long as the PI is responsible for conducting the trial and has sufficient data rights.
16. What do I need to do to start a clinical Trial within the Saudi Arabia?
The requirements of the Clinical Trial Regulations must be fulfilled (Sponsor or PI); in general this means that a clinical trial sponsor must be identified and approval from IRB/EC in clinical trial site and approval from SFDA .
More information on the details required to complete the clinical trial application file (clinical trial application for approval) and procedures for submitting an application to an ethics committee can be found on:
www.sfda.gov.sa
17. What are SFDA requirements regarding research team qualifications?
The SFDA Regulations state that all members involved in clinical trial should have relevant education and experience in medical research and receive training in Good Clinical Practice commensurate with their roles and responsibilities. In order to demonstrate the training has occurred, documentation should be maintained and retained.
18. What documentation needs to be maintained relating to clearance of drug used in clinical trials?
SFDA regulation state the importance of such requirements but are not limited to the following:
Headed letter from the agent to VP of drug affaires.
Approval of clinical trial department to conduct the trial
Sponsor name, Study drug name, quantity and port of clearance.
More information on the details required to finalize drug shipment used in clinical trial can be found on:
www.sfda.gov.sa
19. Do we need to notify the SFDA of protocol amendments?
The SFDA does require protocol amendments to be notified by sponsors where the amendments seek to clarify the use of, and/or monitoring of treatment. Also, SFDA require the ethics committees approval for such amendment.