PSUR Central – Global PSUR & PBRER Services
Strategic Compliance for New Zealand’s Pharma Sector: Medsafe | ICH | EMA | TGA
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Benefit-Risk Evaluation Report (PBRER) and PSUR services tailored for New Zealand’s pharmaceutical sponsors and distributors.
With New Zealand’s regulatory landscape undergoing significant updates in 2024 and 2025—including the enforcement of the Guideline on the Regulation of Therapeutic Products (Edition 3.0)—maintaining "Medsafe-ready" safety documentation is essential. We support sponsors in Auckland, Wellington, and Christchurch to ensure that all aggregate reports satisfy the clinical and technical requirements of Medsafe and the New Zealand Pharmacovigilance Centre (NZPhVC).
Who We Support in New Zealand
We provide specialized pharmacovigilance expertise to the key players in the Aotearoa pharmaceutical market:
Innovative Medicine Sponsors: Drafting PBRERs for new medicines, biologics, and advanced therapy medicinal products (ATMPs) that have been approved in New Zealand for less than five years.
National Schedule Suppliers: Supporting companies with products on the National Immunisation Schedule or funded by Pharmac in meeting specialized safety reporting mandates.
Generic & Biosimilar Exporters: Managing safety reporting for products registered via the abbreviated evaluation process (leveraging TGA or EMA approvals).
Clinical Trial Sponsors: Preparing safety summaries and managing SUSAR reporting for trials conducted at New Zealand’s world-class research sites.
Local Pharmacovigilance Contact Persons: Providing technical medical writing and signal detection support to the designated local safety officers.
Our PBRER & PSUR Services
We offer scientific excellence that aligns with New Zealand’s rigorous "safety-first" regulatory culture:
ICH E2C (R2) Compliant PBRERs: Professional drafting of the PBRER, which has officially replaced the PSUR format for Medsafe submissions.
EURD & TGA Alignment: Synchronizing submission cycles with the EU Reference Date (EURD) list or Australian TGA timelines, as permitted by Medsafe.
Local Signal Detection & Literature Monitoring: Conducting specialized 3-monthly literature reviews of local and global scientific databases to identify New Zealand-specific safety signals.
Serious Safety Issue (SSI) Reporting: Assisting in the 72-hour reporting mandate for Significant Safety Issues that alter the benefit-risk balance.
Benefit-Risk Synthesis: High-level clinical evaluations for high-risk and intermediate-risk medicines, ensuring the ongoing safety narrative is scientifically robust.
Why Pharma Leaders in NZ Choose PSUR Central
"Scientific rigor for New Zealand’s evolving therapeutic product regulations."
2025 Guideline Specialists: We are fully versed in the July 2024/2025 updates to Medsafe's pharmacovigilance requirements, ensuring your submissions avoid costly Requests for Information (RFIs).
Reliance Pathway Expertise: We specialize in "reliance-based" safety dossiers, ensuring that reports prepared for the TGA or EMA are correctly localized for Medsafe acceptance.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically sound.
Medsafe-Ready Submissions: Experience with Medsafe's specific electronic dossier policy, ensuring seamless technical acceptance.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Medsafe GRTPNZ Part 8: The definitive New Zealand guideline for Pharmacovigilance (Edition 3.0).
Medicines Act 1981: The underlying legislative framework for therapeutic products in NZ.
ICH E2C (R2): The global benchmark for periodic benefit-risk reporting.
TGA/EMA Guidelines: For products registered under the abbreviated or priority evaluation pathways.
Get Started: Partner With Us
To initiate a customized project for your New Zealand-based operations, we typically require:
Product Portfolio and target markets (NZ, Australia, Global).
Approved Data Sheets: The current New Zealand Data Sheet and Consumer Medicine Information (CMI).
Estimated Patient Exposure: Units sold or patient-years (NZ-specific and Global).
Summary of ICSRs: Line listings from the New Zealand Pharmacovigilance Database and your global safety database.
Submission Schedule: Coordination with Medsafe's requested timelines or the EURD list.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.