Reviewed by Dr. Rasha Ringa, Founder & General Manager, PKCS. Last reviewed: April 2026.
Running a clinical trial in Iraq requires regulatory submission to the Iraqi Ministry of Health, ethics committee approval, and import permits for investigational medicinal products — all aligned with ICH-GCP overlaid with country-specific procedures. PKCS supports sponsors and contract research organizations through every step. See our clinical research support services and the Iraq drug registration pillar guide for how trial data ties into eventual marketing authorization.
Clinical research in Iraq presents both opportunities and regulatory considerations. As the pharmaceutical sector develops, understanding the local requirements for conducting clinical trials is important for companies planning research activities in the country.
Regulatory Submissions
Clinical trials in Iraq require regulatory approval from the Ministry of Health. The submission process includes a detailed protocol, investigator qualifications, informed consent documents, and supporting safety data. Companies should allow adequate time for the review process.
Ethics Committee Review
All clinical research involving human subjects must receive approval from an ethics committee. The application should include the study protocol, patient information sheets, informed consent forms, and investigator CVs. Ethics review focuses on patient safety, scientific validity, and informed consent procedures.
Good Clinical Practice
Clinical trials should be conducted in accordance with Good Clinical Practice (GCP) guidelines. GCP provides the framework for ensuring that clinical data is credible and that the rights, safety, and wellbeing of trial participants are protected.
Documentation and Oversight
Proper documentation is critical throughout the trial lifecycle. This includes maintaining the Trial Master File, recording adverse events, tracking protocol deviations, and preparing study reports. Ongoing oversight ensures compliance with the approved protocol and applicable regulations.
PKCS provides clinical research support services, including regulatory submissions, ethics committee applications, GCP guidance, and study coordination for companies conducting trials in Iraq. Contact us to discuss your clinical research needs.
Related resources
- PKCS Clinical Research Support — CTA preparation, ethics committee submission, GCP advisory.
- Pillar guide: Drug Registration in Iraq — How clinical data supports MOH approval.
- Pharmacovigilance Services — SUSAR reporting and trial-phase safety monitoring.
- PKCS Regulatory Affairs — Use trial data to support marketing authorization across MENA.
Talk to PKCS about your regulatory pathway
PKCS works with pharmaceutical, biotechnology, and medical device companies entering or expanding across Iraq, the UAE, Saudi Arabia, and the wider GCC. Get in touch for a confidential discussion.