QATAR
QATAR
Medwisdom Lifescience provides comprehensive, MoPH-compliant pharmacovigilance services tailored for the Qatar market. Our expert team ensures seamless ADR reporting, PSUR/PBRER submission, RMP development, and full regulatory compliance.
Overview
Pharmacovigilance (PV) in Qatar focuses on ensuring the safe and effective use of medicines across the country. Drug safety activities are supervised under the Ministry of Public Health (MoPH) through hospitals, healthcare institutions, and drug-control units.
Although Qatar does not yet have a fully centralized national PV center, Adverse Drug Reaction (ADR) reporting systems operate in major public hospitals, and MoPH encourages all healthcare professionals to report safety concerns.
For pharmaceutical companies, maintaining an effective PV system is essential to meet local expectations, safeguard patients, and support regulatory compliance.
Current Pharmacovigilance Landscape in Qatar
Published data provides an accurate picture of PV activity in Qatar:
Key Findings from Scientific Studies
- A study among pharmacists reported that 29.3% had never submitted an ADR report, despite having good knowledge about ADRs.
Source: PubMed - Major barriers included:
• Difficulty recognising ADRs
• No access to reporting forms
• Lack of feedback after reporting
Source: WHO EMRO - Hospital-based PV systems exist, mainly in public/tertiary hospitals, but private hospitals and community pharmacies contribute very few reports.
Source: OVID
What This Means for Companies
- Ongoing safety monitoring
- Compliance with global ICH expectations
- Readiness for future audits and renewals
- Rapid handling of all ADRs related to their products
Our Pharmacovigilance Services for Qatar
- ADR Collection & Case Management
Spontaneous ADRs, Serious & non-serious cases, Literature cases, Follow-up communication, ICSR preparation in CIOMS format - Signal Detection & Risk Assessment
Routine signal detection, Trend analysis of ADRs, Benefit–risk evaluation, Escalation and corrective actions - Periodic Safety Reports (PSUR/PBRER)
PSURs / PBRERs, Benefit–risk evaluations, Safety update summaries for product registration and renewal
- Risk Management Plans (RMP)
RMP development, Local Qatar adaptation, Safety monitoring recommendations, Risk minimization measures - Pharmacovigilance System Setup
Global + local SOP preparation, Safety database setup, Complaint management workflow, Quality management and documentation - Training & Audits
PV training for medical, regulatory, sales, and distribution staff, Internal audits, Audit preparation for MoPH observations
Why PV Compliance Matters in Qatar
- Prompt reporting of serious safety concerns
- Responsible monitoring of marketed medicines
- Transparent communication about product risks
- Safety updates during variations & renewals
Having an end-to-end PV partner ensures fast registration, trouble-free renewals, and strong compliance.
Important Timelines for Qatar
Since Qatar aligns with international ICH safety principles, the following timelines are commonly accepted in practice:
| Activity | Expected Timeline |
|---|---|
| Serious ADR reporting | Within 15 calendar days |
| Non-serious ADR reporting | Within 30 days |
| PSUR/PBRER submission | As per ICH cycle (6-monthly, yearly, or 3-yearly) |
| RMP submission | With registration or when required |
| Safety updates during renewal | Mandatory 5-year safety summary |
Useful Official Links
- Ministry of Public Health, Qatar → www.moph.gov.qa
- Scientific PV Studies in Qatar
• WHO EMRO Study
• PubMed Study - Drug Product Registration → omcmedical.com