Reviewed by Dr. Rasha Ringa, Founder & General Manager, PKCS. Last reviewed: April 2026.
Pharmacovigilance is a non-negotiable obligation for marketing authorization holders in Iraq, the UAE, Saudi Arabia, and across the GCC. Each authority — the Iraqi MOH, MOHAP/EDE, and the Saudi NPC under SFDA — operates its own reporting framework with country-specific timelines, qualified person (QPPV) requirements, and periodic safety report cadences. PKCS designs and operates pharmacovigilance systems that meet all three. See our pharmacovigilance services overview for what an engagement covers.
Growing Regulatory Expectations
Health authorities across the Middle East are aligning their safety requirements with international standards. Companies operating in Iraq and neighboring markets are expected to establish pharmacovigilance systems that include adverse event reporting, signal detection, and periodic safety reporting.
Local Safety Representation
Many countries in the region require companies to designate a local safety representative. This person or organization is responsible for collecting safety data, submitting reports to authorities, and serving as the point of contact for safety-related matters.
Building a Pharmacovigilance System
Establishing a functional pharmacovigilance system involves several components: a Pharmacovigilance System Master File (PSMF), standard operating procedures for case processing, qualified personnel, and clear communication channels with regulatory authorities.
Periodic Safety Reports
Companies are required to submit periodic safety update reports (PSURs/PBRERs) that summarize the benefit-risk profile of their products. These reports require systematic data collection and analysis.
PKCS provides comprehensive pharmacovigilance support, from system setup to ongoing local safety representation, helping companies meet their regulatory obligations in Iraq and the broader region. Contact us to discuss your pharmacovigilance needs.
Related resources
- PKCS Pharmacovigilance Services — QPPV, ICSR processing, PSURs, signal management across MENA.
- Pillar guide: Drug Registration in Iraq — Comprehensive guide including post-approval pharmacovigilance obligations.
- PKCS Regulatory Affairs — End-to-end dossier preparation and lifecycle management.
- Local Representative Services — PV contact role for foreign manufacturers in 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.