PSUR Central – Global PSUR & PBRER Services
To adapt the PSUR Central webpage for the Beninese market, the messaging highlights the nation’s transition toward a modernized regulatory framework under the Beninese Medicines Agency (ABMed) (formerly DPM) and the Benin Standard Organization (BSO). It emphasizes compliance with WAEMU (UEMOA) harmonization and the 2025 focus on mandatory Post-Market Surveillance and Pharmacovigilance (PV) reporting.
PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for Benin’s Emerging Healthcare Sector: ABMed | BSO | WAEMU | 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 Benin.
As Benin moves toward WHO Maturity Level 3 for its regulatory functions, the Agence Béninoise de Régulation et d’Enregistrement des Produits (ABMed) is enforcing stricter pharmacovigilance (PV) mandates for all Marketing Authorization Holders (MAHs). In 2025, with the full implementation of the WAEMU (UEMOA) Harmonized Regulatory Framework, international exporters and local distributors must provide scientifically rigorous safety reports to maintain market access in Cotonou and Porto-Novo.
Who We Support in Benin
We provide specialized pharmacovigilance expertise across Benin’s pharmaceutical supply chain:
International Pharmaceutical Exporters: Managing aggregate reporting for medicines imported from Europe, India, and China, ensuring they meet ABMed’s registration requirements.
Local Pharmaceutical Manufacturers: Supporting Benin’s domestic production capacity with the implementation of internal PV systems and first-time PSUR drafting.
Authorized Representatives (Exploitants): Assisting local representatives in managing safety inquiries from the National Pharmacovigilance Centre (NPC) and the BSO.
NGOs & Aid Organizations: Providing safety data summaries for essential medicines and vaccines used in national healthcare programs and humanitarian efforts.
Clinical Trial Sponsors: Drafting Development Safety Update Reports (DSURs) for studies conducted under the oversight of the National Ethics Committee for Health Research (CNERS).
Our PSUR & PBRER Services
Our scientific precision aligns with Benin’s commitment to providing safe and quality-assured medicines to its population:
WAEMU-Harmonized PBRER Preparation: Expert drafting in the ICH E2C (R2) format, synchronized with the ASEAN-like ACTD standards adopted by the West African Economic and Monetary Union.
Post-Market Surveillance (PMS) Support: Assisting firms in fulfilling the mandatory reporting of Individual Case Safety Reports (ICSRs) and aggregate updates to the BSO Pharmacovigilance Unit.
Benefit-Risk Synthesis: High-level medical evaluations that justify the safety profile of products within the West African clinical context, supporting product renewals.
French-Language Documentation: While scientific dossiers are often in English, we provide the technical summaries and safety narratives required in French for official ABMed submissions.
Signal Detection & Analysis: Utilizing scientific methodologies to validate and assess safety signals, incorporating data from the VigiBase (WHO) system, to which Benin is a member.
Why Pharma Leaders in Benin Choose PSUR Central
"Scientific excellence to bridge the gap between global standards and Benin's regulatory requirements."
ABMed Specialist Expertise: We track the latest circulars from the Beninese Medicines Agency, ensuring your reports are ready for the Evaluation and Registration Department.
WAEMU Regional Consistency: Our reports are designed to be "submission-ready" across the entire UEMOA region, facilitating cross-border compliance.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
Audit-Ready Quality: Our reports have a 100% acceptance track record across global regulatory agencies (EMA, US FDA, and African NRAs).
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Benin National Drug Policy: The foundational framework for medicines regulation in the Republic.
WAEMU (UEMOA) Regulation No. 06/2010/CM: Regarding the harmonization of pharmaceutical product registration.
WHO Good Pharmacovigilance Practices: The global benchmark used by the BSO to strengthen national safety monitoring.
ICH E2C (R2): The international gold standard for periodic benefit-risk reporting.
Get Started: Partner With Us
To initiate a customized project for your operations in Benin, we typically require:
Product Portfolio and current registration status with the ABMed.
Approved Labeling: The SmPC (Summary of Product Characteristics) and the French-language Patient Information Leaflet (PIL).
Estimated Patient Exposure: Units sold or patient-years (Global and Benin-specific).
Summary of ICSRs: Line listings and tabulations from the National Pharmacovigilance Centre or your global database.
Submission Calendar: Coordination with your 5-year registration renewal cycles or specific BSO monitoring requests.
Contact PSUR Central today to ensure your pharmaceutical safety compliance in Benin is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.