PSUR Central – Global PSUR & PBRER Services
Elite Compliance for the Maldives’ Growing Market: MFDA | Reliance Pathways | ICH | WHO
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for the pharmaceutical sector in the Republic of Maldives.
The Maldives is rapidly modernizing its healthcare infrastructure, with the Maldives Food and Drug Authority (MFDA) leading the transition toward international safety standards. As of 2025, the MFDA has implemented the 3rd Edition (Tenth Revision) of the Drug Registration Guidance Document (DRGD), emphasizing Reliance Pathways that utilize assessments from recognized global authorities. For international manufacturers and local importers, maintaining robust safety documentation is no longer just a requirement—it is the foundation of market trust in the Maldives.
Who We Support in the Maldives
We provide specialized pharmacovigilance expertise across the Maldivian health landscape:
International Pharmaceutical Exporters: Managing PBRER cycles for products entering the Maldives via Verification or Abridged Review pathways from Reference Regulatory Authorities (RRAs).
Registered Medicine Importers: Providing the technical back-end safety data required for submission via the Dhirithi Portal for product registration and pre-authorization.
National Health Program Suppliers: Drafting aggregate safety reports for essential medicines and vaccines distributed through the Aasandha national health insurance scheme.
Nutraceutical & Supplement Brands: Ensuring compliance with the MFDA Guideline on Registration of Health Supplements (2025), including safety claim substantiation.
Clinical Research Partners: Assisting with safety monitoring and reporting for specialized medical countermeasure evaluations and public health initiatives.
Our PSUR & PBRER Services
Our scientific precision aligns with the MFDA’s focus on the quality, safety, and efficacy of all therapeutic goods:
Reliance-Ready PBRER Preparation: Expert drafting in the ICH E2C (R2) format, designed to satisfy MFDA requirements when leveraging approvals from the EMA, US FDA, or WHO.
Post-Market Surveillance (PMS) Support: Assisting importers in fulfilling the mandatory 6-monthly market safety data reporting required for medicines imported from accredited hospitals and international sources.
Benefit-Risk Synthesis: High-level medical evaluations that justify the continued use of products within the Maldivian clinical environment, particularly for Emergency Use Authorizations (EUA).
Signal Detection & ADR Management: Utilizing scientific methodologies to assess adverse drug reactions (ADRs) reported to the National Pharmacovigilance Centre in Malé.
2025 Guideline Integration: Ensuring all dossiers reflect the latest July 2025 DRGD updates, including specialized requirements for orphan drugs and biologics.
Why Pharma Leaders in the Maldives Choose PSUR Central
"Scientific rigor for the Maldives' evolving and reliance-driven regulatory framework."
2025 MFDA Specialist Expertise: We are fully versed in the 2025 MFDA Service Charter and the latest digital submission protocols, ensuring your registration cycles remain uninterrupted.
Efficiency Through Reliance: We specialize in aligning global safety dossiers with the MFDA's reliance principles, significantly reducing the time-to-market for innovative therapies.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust for the Technical Committee of MTG.
Global Acceptance: Our reports have a perfect track record with the MFDA, the WHO, and major reference authorities worldwide.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Drug Registration Guidance Document (DRGD 2025): The primary reference for registration and post-registration activities in the Maldives.
Guideline on Pharmacovigilance and ADR Reporting: The national framework for safety monitoring and risk mitigation.
Guideline on Good Reliance Practices: Leveraging international assessments for expedited regulatory decision-making.
ICH E2C (R2): The global benchmark for periodic benefit-risk reporting.
Get Started: Partner With Us
To initiate a customized project for your operations in the Maldives, we typically require:
Product Portfolio and your preferred evaluation route (Full, Abridged, or Verification).
RRA Documentation: Copies of registration and RMP (Risk Management Plan) from Reference Regulatory Authorities.
Approved Labeling: The SmPC/PIL and the proposed Maldivian label as per MFDA requirements.
Local Safety Data: Any ADR reports collected through your Maldivian distribution network or the Dhirithi Portal.
Submission Timeline: Coordination with your 1-year conditional review or 5-year renewal cycles.
Contact PSUR Central today to ensure your pharmaceutical safety compliance in the Maldives is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.