The Saudi Food and Drug Authority (SFDA) is Saudi Arabia’s national regulator for drugs, biologics, medical devices, and food safety, and it is the competent authority sponsors must obtain authorization from before conducting a clinical trial in the Kingdom. Alongside SFDA’s own authorization decision, every trial must also be entered into the Saudi Clinical Trials Registry (SCTR), the online platform SFDA operates at sctr.sfda.gov.sa that functions both as the national trial registry and as the intake system for the Clinical Trial Application itself. This guide covers what SFDA authorizes, how the SCTR-based application pathway works, who is eligible to apply, and what a sponsor’s ongoing obligations are once a trial is authorized.
What SFDA Is and What It Authorizes
SFDA was established as Saudi Arabia’s independent regulatory authority for pharmaceuticals, biologics, medical devices, and related health products, and its remit includes pre-market authorization of clinical trials conducted in the country. SFDA has published dedicated regulatory guidance on conducting clinical trials of drugs, distinct from its bioequivalence-study framework and from its separate medical-device clinical investigation requirements — a structural split similar to how other national regulators (for example India’s CDSCO or Brazil’s ANVISA) separate drug-trial and device-trial pathways. Before a sponsor can dose a human subject in Saudi Arabia, both SFDA authorization of the trial and a local research ethics committee (REC) approval of the protocol must be in place; SFDA authorization does not substitute for ethics review, and ethics approval alone does not substitute for SFDA authorization — the two run as parallel, complementary requirements, the same two-track model used across most ICH-aligned jurisdictions.
The Clinical Trial Application (CTAp) Pathway via SCTR
Sponsors initiate a Clinical Trial Application (CTAp) by creating an account on the SCTR portal and submitting the application electronically through it. In practice this means the registry is not a separate, downstream reporting step layered on top of an independent SFDA filing — SCTR is the system of record sponsors use to both register the trial and route the authorization request to SFDA. A submission package assembled for SCTR typically needs to include the trial protocol, a valid Good Manufacturing Practice (GMP) certificate for the investigational drug, a delegation-of-duties log identifying the trial’s local personnel, and the local REC’s approval letter for the protocol.
SFDA’s published clinical-trial regulations also require the clinical trial agreement between sponsor and site to be submitted in bilingual form (Arabic and English), reviewed by the sponsor’s legal department or a licensed attorney before submission. Because SFDA has not published a single fixed statutory review-decision timeline that is stable and independently verifiable at the level of specificity this guide requires, sponsors should treat published third-party estimates of CTAp turnaround as indicative rather than authoritative, and confirm current expected timelines directly against SFDA’s own published guidance or through a licensed local regulatory contact before building a submission timeline around a specific day-count.
Who Can Apply: Local Presence and the Saudi National Requirement
A sponsor with its own registered legal entity in Saudi Arabia can submit a CTAp directly. A sponsor without a Saudi legal presence must instead work through a licensed Saudi-based Clinical Research Organization (CRO) to submit and manage the application — the CRO itself must hold an establishment license issued in the Kingdom authorizing it to act in that capacity. This mirrors the local-representative requirement seen in several other emerging-market regulatory systems CASRAI has covered, including Egypt’s EDA and Nigeria’s NAFDAC pathways.
SFDA’s clinical-trial regulations also require the appointment of a full-time Saudi national responsible for clinical trials at the sponsor or CRO, holding at minimum a bachelor’s degree in an appropriate field and at least three years of clinical-trial experience. This individual functions as the accountable local point of contact for SFDA on the conduct of the trial, distinct from (though often working alongside) the site’s principal investigator and the trial’s clinical research associates or coordinators.
SCTR Registration Specifically: What It Covers
The Saudi Clinical Trials Registry has operated as a mandatory public registration system for trials conducted in the Kingdom since 2013. Beyond its role as the CTAp submission portal, SCTR also serves the transparency function common to national and regional trial registries elsewhere — comparable in purpose, though not identical in scope or governance, to ClinicalTrials.gov registration in the United States. A trial’s SCTR registration record is the reference point SFDA, ethics committees, and the public draw on to confirm a study’s authorized status, its sponsor and site details, and its protocol summary. Sponsors running a multi-country trial that includes a Saudi site should plan for SCTR registration as a distinct, non-optional step alongside — not a substitute for — any other trial registry the sponsor is separately obligated to use (such as ClinicalTrials.gov or the WHO International Clinical Trials Registry Platform network).
Ongoing Obligations After Authorization
Authorization is not a one-time gate. Once a trial is underway, sponsors and their local CRO or legal representative in Saudi Arabia have continuing reporting and record-keeping duties to SFDA, including:
- Serious adverse reaction reporting. Suspected unexpected serious adverse reactions (SUSARs) — both those occurring locally in Saudi Arabia and, for multi-country trials, relevant global cases — must be reported to SFDA promptly, with an initial report due no later than 15 days from when the sponsor becomes aware of the event, followed by any necessary follow-up report. This 15-day expedited-reporting window is consistent with the SUSAR reporting timelines used in most ICH-aligned regulatory systems.
- Essential document and data retention. The sponsor or its Saudi representative must retain the trial’s essential documents and generated data for a defined minimum period after the trial ends or the investigational product is registered with SFDA — sponsors should confirm the exact current retention-period rule against SFDA’s published regulation directly, since retention requirements of this kind are periodically revised and the precise trigger event and duration are load-bearing for a compliance program.
- Protocol amendments and deviations. Material changes to an authorized protocol generally require a corresponding update through SFDA/SCTR before implementation, following the same logic covered in CASRAI’s guide to major protocol deviations and IRB reporting steps.
How This Fits the Wider ICH-Aligned Landscape
Saudi Arabia’s clinical-trial framework sits within the broader trend of national regulators aligning their GCP expectations with ICH E6(R3) and related ICH guidance, alongside jurisdictions CASRAI has already covered such as Argentina’s ANMAT, Singapore’s HSA, Turkey’s TITCK, and South Africa’s SAHPRA. For sponsors evaluating Saudi Arabia as part of a wider Gulf or MENA regional footprint, the practical planning takeaway is the same one that applies across most non-ICH-founding-member jurisdictions: budget time for local ethics review in parallel with the SFDA/SCTR submission, confirm CRO/local-representative and local-national-personnel requirements early since they gate who is even eligible to submit, and treat SCTR registration as a mandatory transparency obligation independent of authorization status rather than an afterthought once approval is granted.
Frequently Asked Questions
Is SFDA authorization the same thing as SCTR registration?
They are closely linked but not identical. SFDA is the regulatory authority that authorizes a clinical trial; SCTR is the online registry and application portal SFDA operates, through which the Clinical Trial Application is actually submitted and through which the trial’s public registration record is maintained. In practice, a sponsor works through SCTR to obtain SFDA’s authorization, so the two steps happen through the same system rather than as two separate filings.
Can a foreign sponsor with no Saudi office apply directly to SFDA?
No. A sponsor without a registered legal entity in Saudi Arabia must submit and manage its application through a licensed Saudi-based Clinical Research Organization that holds a Saudi establishment license authorizing it to act as a CRO.
Does SFDA require a local ethics committee approval in addition to its own authorization?
Yes. Local research ethics committee (REC) approval of the protocol and SFDA’s authorization of the trial are separate, parallel requirements — SFDA authorization does not remove the need for local ethics review, and vice versa.
What is the required qualification for the local person responsible for a trial in Saudi Arabia?
SFDA’s clinical-trial regulations call for a full-time Saudi national responsible for clinical trials at the sponsor or CRO, holding at least a bachelor’s degree in an appropriate field and a minimum of three years of clinical-trial experience.
How quickly must a serious adverse reaction be reported to SFDA?
Suspected unexpected serious adverse reactions (SUSARs) must be reported to SFDA as soon as possible, with an initial report required no later than 15 days after the sponsor becomes aware of the event, followed by a follow-up report as needed.
This guide reflects SFDA’s published clinical-trial regulatory framework and SCTR’s role as of 2026. Regulatory timelines, fees, and document checklists are subject to periodic revision by SFDA — sponsors preparing an actual submission should confirm current requirements directly against SFDA’s published guidance at sfda.gov.sa and the SCTR portal, or through a licensed local regulatory affairs contact, rather than relying solely on this overview.
