Your Local Pharmacovigilance Partner for Drug Safety in Qatar
DDReg provides pharmacovigilance services in Qatar for pharmaceutical and medical device marketing authorisation holders. Our team operates local PV systems for foreign MAHs, manages MoPH adverse event reporting within stipulated timeframes, prepares Periodic Safety Update Reports (PSURs), implements risk minimisation strategies, and delivers pharmacovigilance outsourcing Qatar mandates across pharmaceuticals, biologics, and medical devices.
Qatar Pharmacovigilance Framework
The Ministry of Public Health (MoPH) governs pharmaceutical and medical device regulation in Qatar. Within the MoPH, the Pharmacy and Drug Control Department (PDCD) administers drug product registration and post-market surveillance. Qatar has developed PV guidelines emphasising detailed reporting procedures for adverse events with clear timelines based on event severity, PSUR submission requirements, and collaboration with international pharmacovigilance databases including WHO VigiBase.
Foreign MAHs must establish a clear pharmacovigilance system to report adverse events and product-related issues to the MoPH within stipulated timeframes. Qatar encourages alignment with international standards from FDA, EMA, and MHRA while maintaining GCC-specific reporting obligations. The recent emphasis on training and awareness requires organisations to train staff involved in adverse event reporting and evaluation. Medical device adverse event reporting follows GHTF-aligned frameworks under MoPH oversight.
Pharmacovigilance Outsourcing Qatar - DDReg Services
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Local PV System and Adverse Event Reporting
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Drug Safety Services Qatar - PSURs and Risk Management
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Regulatory Compliance and Training
Qatar Pharmacovigilance Reporting Requirements
| Obligation | Requirement | Authority |
|---|---|---|
| Adverse event reporting - serious events | Within stipulated timeframe based on event severity | MoPH PDCD |
| PSUR (Periodic Safety Update Reports) | As required per registration obligations | MoPH PDCD |
| Risk minimisation strategies | Development and implementation as required | MoPH PDCD |
| Staff training on PV | Training for personnel involved in adverse event reporting | MoPH guideline expectation |
| Medical device adverse events | Per GHTF-aligned framework timelines | MoPH PDCD |
| Collaboration with international databases | Encouraged reporting to WHO VigiBase and other global systems | MoPH guidance |
Pharmacovigilance Company in Qatar - DDReg Expertise
DDReg understands Qatar's PV framework as governed by the MoPH and operationally administered by the PDCD. Our team manages adverse event reporting within the timelines stipulated by MoPH based on event severity, prepares PSURs as required under individual product registrations, and implements risk minimisation strategies tailored to the Qatari healthcare system. Qatar's alignment with international standards- FDA, EMA, MHRA combined with GCC-specific obligations requires coordinated global and regional reporting.
Qatar encourages collaboration with international pharmacovigilance databases including WHO VigiBase. DDReg coordinates dual reporting MoPH-mandated submissions for Qatar regulatory compliance and voluntary contributions to international databases for signal strengthening. For products registered through the GCC fast-track pathway, DDReg aligns Qatar PV obligations with broader GCC reporting requirements across member states.
MoPH guidelines emphasise training for staff involved in adverse event reporting and evaluation. DDReg provides PV training for local distributors, medical information teams, and regulatory affairs personnel operating in Qatar covering MoPH reporting obligations, event severity classification, timeline compliance, and PSUR preparation. For foreign MAHs without Qatari operational presence, DDReg serves as the local PV contact managing all MoPH pharmacovigilance communications.
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