PSUR Central – Global PSUR & PBRER Services
Strategic Compliance for the UAE’s New Regulatory Era: EDE | MoHAP | ICH | US FDA
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services specifically designed for the UAE’s rapidly evolving pharmaceutical landscape.
2025 marks a "New Era" for the UAE pharmaceutical sector with the enforcement of Federal Law No. 38 of 2024 and the operational launch of the Emirates Drug Establishment (EDE). As the UAE centralizes its regulatory authority to become a global life sciences powerhouse, Marketing Authorization Holders (MAHs) in Dubai, Abu Dhabi, and Sharjah must navigate stricter pharmacovigilance (PV) mandates. Since 2008, we have supported UAE-based firms in ensuring their safety dossiers meet the highest international standards while remaining fully compliant with local MoHAP and EDE requirements.
Who We Support in the UAE
We provide specialized pharmacovigilance expertise to the key players in the Arab world’s most advanced pharma hub:
Domestic Manufacturing Leaders: Supporting UAE-based giants in Ras Al Khaimah and Abu Dhabi with global aggregate reporting for diverse export portfolios.
Regional Marketing Offices (Dubai Science Park): Assisting multinational regional HQs in managing the UAE-specific "Local Contact Person for PV" (LCPPV) requirements and aggregate reporting.
Biotech & Innovative Startups: Drafting PBRERs and Risk Management Plans (RMPs) for cutting-edge therapies, including advanced treatments and orphan drugs regulated under the new law.
Scientific Offices & Medical Stores: Ensuring that the designated "Regulatory Hub" for each MAH is equipped with authority-ready safety documentation.
Local QPPVs & Safety Officers: Providing technical support to UAE-resident QPPVs for signal detection, medical writing, and EDE portal submissions.
Our PSUR & PBRER Services
We offer scientific excellence that matches the UAE’s vision for a world-class, digitized healthcare ecosystem:
EDE-Compliant PBRER Preparation: Expert drafting in the ICH E2C (R2) format, aligned with the UAE GVP Guidelines (ver 1.3) and the new 2025 mandates.
National Electronic System Submissions: Managing the technical requirements for reporting safety data through the EDE’s new centralized digital platforms.
Local Signal Detection & Management: Utilizing scientific methodologies to monitor and validate safety signals specifically for the UAE patient population.
Bilingual Documentation Support: Ensuring that all summary safety information and labeling updates comply with the UAE’s strict Arabic and English requirements.
Benefit-Risk Evaluations: High-level clinical assessments that justify the continued marketing of your products under the EDE’s stricter post-market surveillance.
Why Pharma Leaders in the UAE Choose PSUR Central
"Scientific rigor for the Middle East’s most innovative regulatory landscape."
2025 Law Specialists: We are fully versed in the transition from Federal Law No. 8 of 2019 to the New Law (No. 38 of 2024), ensuring your PV system is updated for the one-year grace period.
Science-Driven Quality: We move beyond data entry to provide deep-dive clinical evaluations that satisfy the EDE’s focus on enhanced consumer safety and market clarity.
Seamless Local Integration: We understand the unique UAE requirement for a resident QPPV and a documented Pharmacovigilance Plan for every product registration.
100% Acceptance Track Record: Our reports are designed to withstand the technical scrutiny of the EDE’s newly consolidated technical committees.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
UAE GVP Guidelines (v1.3): The current benchmark for Good Vigilance Practice in the Emirates.
Federal Law No. 38 of 2024: The new governing law for medical products and pharmacovigilance.
ICH E2C (R2): The global gold standard for PBRER/PSUR.
EDE Technical Mandates: Specific requirements for orphan drugs, biopharmaceuticals, and innovative treatments.
Get Started: Partner With Us
To initiate a customized project for your UAE-based operations, we typically require:
Product Portfolio and target markets (UAE, GCC, Global).
Approved Labeling: The bilingual (Arabic/English) SmPC or Physician's Leaflet.
Estimated Patient Exposure: Units sold or patient-years (UAE-specific and Global).
Summary of ICSRs: Line listings and tabulations from the UAE market and your safety database.
Submission Schedule: Coordination with EDE/MoHAP registration renewal cycles (typically every 5 years).
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.