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.