PSUR Central – Global PSUR & PBRER Services
Elite Compliance for Morocco’s Healthcare Sovereignty: AMMPS | CNPV | ICH | EMA Harmony
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 and biotech sectors in the Kingdom of Morocco.
Morocco is undergoing a "social revolution" in healthcare, with the goal of universal health coverage by 2025 under Framework Law No. 09.21. As part of this transition, the Moroccan Agency for Medicines and Health Products (AMMPS)—which held its inaugural Board of Directors meeting in March 2025—is now the primary authority overseeing market access and drug safety. With a strategic focus on local manufacturing and export potential into the MENA and African markets, Morocco now requires safety dossiers that are scientifically rigorous, digital-ready, and harmonized with international best practices.
Who We Support in Morocco
We provide specialized pharmacovigilance expertise across Morocco’s "Atlantic-Mediterranean" pharmaceutical hub:
Multinational Pharmaceutical Leaders: Managing global PBRER cycles for innovative medicines registered in Morocco, ensuring alignment with AMMPS and Law 17-04 standards.
Local Moroccan Manufacturers (Laboratoires Pharmaceutiques): Supporting the Kingdom's growing domestic industry in Casablanca and Rabat with "Export-Ready" safety dossiers.
MAH Authorized Representatives: Providing the technical scientific bandwidth required by local agents to manage CNPV (National Pharmacovigilance Centre) queries and signal detection.
Biosimilar & Generics Pioneers: Drafting safety evaluations for the 112 pharmaceutical products receiving major 2025 tariff reductions to enhance national health security.
Clinical Research Partners: Assisting with DSUR preparation for clinical trials conducted under the oversight of the National Ethics Committee.
Our PSUR & PBRER Services
Our scientific precision aligns with the AMMPS’s focus on transparency, efficiency, and international standards:
EMA-Harmonized PBRER Preparation: Expert drafting in the ICH E2C (R2) format, designed to satisfy AMMPS reviewers who prioritize harmonization with European Medicines Agency (EMA) standards.
2025 Digital Strategy Support: Assisting MAHs in preparing safety dossiers for Morocco’s emerging digital review systems and e-portal submissions.
Benefit-Risk Synthesis & Medical Writing: High-level clinical evaluations provided in French or English, as required for the technical file assessment by the National Commission of MAs.
Signal Detection & ADR Management: Utilizing scientific methodologies to validate safety signals from the CNPV database and global sources like VigiBase.
Market Surveillance Compliance: Ensuring aggregate reports reflect mandatory reserve stock compliance and local post-market monitoring requirements.
Why Pharma Leaders in Morocco Choose PSUR Central
"Scientific rigor for the Kingdom's modernizing and high-growth pharmaceutical landscape."
2025 AMMPS Specialists: We are fully operational under the new AMMPS administrative model, ensuring your product renewals and safety updates are authority-ready.
Law 17-04 & Code of Medicine Proficiency: Fully versed in the Moroccan Pharmaceutical Industry Code, ensuring 100% compliance with local statutory obligations.
Bilingual Technical Excellence: We bridge the gap between global English safety data and the French or Arabic labeling and summary requirements used in Moroccan clinical practice.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Law No. 17-04 (Code of the Medicine and Pharmacy): The foundational legal framework for Moroccan pharmaceutical practice.
Framework Law No. 09.21 (Social Protection): The 2025 mandate for sustainable and secure national health coverage.
Good Pharmacovigilance Practices (GVP) in Morocco: The national standard for safety monitoring and risk management.
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 Morocco, we typically require:
Product Portfolio and registration status (National, Fast-Track, or Exceptional Import).
AMMPS Submission Strategy: Details on your upcoming registration or renewal windows.
Approved Labeling: The SmPC (Summary of Product Characteristics) and Patient Leaflet in French.
Local Safety Data: Summary of serious adverse drug reactions (ADRs) reported within the Moroccan market.
Submission Timeline: Coordination with your 5-year registration validity cycles.
Contact PSUR Central today to ensure your pharmaceutical safety compliance in Morocco is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.