Your trials, with the record in-country.
How ZINOS fits trial approval and health data law in Saudi Arabia, the United Arab Emirates, and Qatar.
How a trial is approved in each market.
Each market has its own regulator and ethics route, and approvals come before the first participant.SourceSFDA, Regulations and Requirements for Conducting Clinical Trials on Drugs, v3.0, 5 January 2025, sfda.gov.saSFDA documents above; NCBE Implementing Regulations v3, 2025DoH, Standard on Human Subject Research, DoH/QD/SD/HSR/0.9, January 2020DHA, Clinical Trials Policy DHA/HRS/HPSD/HP-19, effective 12 June 2023The Peninsula, 25 March 2025; Qatar Tribune, 22 July 2026; Al Tamimi
- Saudi Arabia
- SFDA authorisationSourceSFDA, Regulations and Requirements for Conducting Clinical Trials on Drugs, v3.0, 5 January 2025, sfda.gov.sa
- NCBE-registered ethics committeeSourceSFDA documents above; NCBE Implementing Regulations v3, 2025
- SCTR registrationSourceSFDA, Regulations and Requirements for Conducting Clinical Trials on Drugs, v3.0, 5 January 2025, sfda.gov.sa
- United Arab Emirates
- EDE federal authorisationSourceMoHAP, transfer of selected services to EDE, mohap.gov.ae (undated)
- DoH Abu Dhabi authorisationSourceDoH, Standard on Human Subject Research, DoH/QD/SD/HSR/0.9, January 2020
- DSREC approval, DubaiSourceDHA, Clinical Trials Policy DHA/HRS/HPSD/HP-19, effective 12 June 2023
- Qatar
- MoPH research licenceSourceThe Peninsula, 25 March 2025; Qatar Tribune, 22 July 2026; Al Tamimi
- Approvals before first participant
Where Gulf law says health data may sit.
- UAE: health data stays in-country; ZINOS deploys on hospital serversSourceuaelegislation.gov.ae, Federal Law No. 2 of 2019
- Saudi PDPL: health data is sensitive; records stay under your controlsSourceSDAIA, Guide to the Personal Data Protection Law, dgp.sdaia.gov.sa
- Saudi transfers abroad need safeguards; the record need not leaveSourceSDAIA, Regulation on Personal Data Transfer outside the Kingdom, v2.0, August 2024
- Qatar: processing health data needs permission; every release is loggedSourceLaw No. 13 of 2016, English text via CYRILLA; DLA Piper
Where the record sits in the region.
With on-premise deployment, regulators and sponsors receive what the rules require, and the trial record stays inside your hospital.SourceSFDA documents above; NCBE Implementing Regulations v3, 2025DoH, Standard on Human Subject Research, DoH/QD/SD/HSR/0.9, January 2020DHA, Clinical Trials Policy DHA/HRS/HPSD/HP-19, effective 12 June 2023
- Hospital information system
- Laboratory system
- Imaging and pathology
- Identity and access
- Site operating system
- Data hub
- Local AI node
- Audit trail
- Ethics committee
- National regulator
- Sponsor
- Monitor
Gulf requirements, mapped to ZINOS.
| Requirement | Rule | ZINOS capability |
|---|---|---|
| Health data held in the UAE | Federal Law No. 2 of 2019, Art. 13Sourceuaelegislation.gov.ae, Federal Law No. 2 of 2019 | On-premise deployment in your hospital |
| Records kept 25 years | Federal Law No. 2 of 2019, Art. 20Sourceuaelegislation.gov.ae, Federal Law No. 2 of 2019 | Configurable retention and archival |
| Ethics approval before start | NCBE, DoH, DSREC, MoPHSourceSFDA documents above; NCBE Implementing Regulations v3, 2025DoH, Standard on Human Subject Research, DoH/QD/SD/HSR/0.9, January 2020DHA, Clinical Trials Policy DHA/HRS/HPSD/HP-19, effective 12 June 2023The Peninsula, 25 March 2025; Qatar Tribune, 22 July 2026; Al Tamimi | Approval tracking in the site file |
| Transfers abroad under safeguards | Saudi PDPL transfer regulationSourceSDAIA, Regulation on Personal Data Transfer outside the Kingdom, v2.0, August 2024 | Anonymised extracts, released on your terms |
| Hosting rules for public entities | NDMO at SDAIASourceNCA, CCC-2:2024, Annex D, cdn.nca.gov.sa | Hospital-controlled deployment |
| Each row states a design fact about ZINOS, not a compliance claim. | ||
See ZINOS against Gulf rules.
Book a call on running trials in the Middle East and North Africa, and bring your DPO.