PSUR Central – Global PSUR & PBRER Services

To adapt the PSUR Central webpage for the South African market, the messaging highlights the authority of the South African Health Products Regulatory Authority (SAHPRA) and its 2025 digital transformation. It focuses on the mandatory use of the SAHPRA Engagement Portal, the transition to E2b reporting, and the heightened requirements for Clinical Evaluation Reports (CER) for medical devices.

PSUR Central – Global PSUR & PBRER Services

Elite Compliance for South Africa’s Healthcare Frontier: SAHPRA | ICH | GVP | SADC

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 medical device sectors in the Republic of South Africa.

South Africa is the leading pharmaceutical market in Sub-Saharan Africa, driven by SAHPRA’s commitment to global harmonization and regulatory maturity. As of September 2025, SAHPRA has released updated guidelines for Post-Marketing Reporting (SAHPGL-CEM-PV-04_v10) and launched the SAHPRA Engagement Portal, a unified digital gateway for all regulatory interactions. In this "digital-first" era, Marketing Authorization Holders (MAHs) and Holders of Certificate of Registration (HCRs) must navigate stricter timelines for eCTD/eSubmission and enhanced vigilance for AI-enabled medical devices.

Who We Support in South Africa

We provide specialized pharmacovigilance expertise across the nation’s advanced health technology sector:

• Holders of Certificate of Registration (HCRs): Managing the technical burden of aggregate reporting to ensure compliance with the Medicines and Related Substances Act (101/1965).

• Innovative Biotech & Biological Firms: Drafting complex PBRERs for South Africa’s growing biologics and biosimilar portfolio, aligned with SAHPGL-PEM-BIO-02 standards.

• Medical Device & IVD Manufacturers: Meeting the 2025 requirements for Clinical Evaluation Reports (CER) and post-market performance monitoring as per the new SAHPGL-MD-16 guidelines.

• Local Pharmacovigilance Officers (LPO): Providing the technical scientific bandwidth required to manage E2b reporting and the mandatory 2025 PSMF (Pharmacovigilance System Master File) submissions.

• Clinical Trial Sponsors: Drafting Development Safety Update Reports (DSURs) for multi-center trials under the oversight of the National Health Research Ethics Council (NHREC).

Our PSUR & PBRER Services

Our scientific precision aligns with SAHPRA’s drive for regulatory efficiency and international reliance:

• Portal-Ready PBRER Preparation: Expert drafting in the ICH E2C (R2) format, optimized for direct upload via the SAHPRA Engagement Portal.

• 2025 Medical Device Vigilance: Specialized CER and PMS (Post-Market Surveillance) reporting that demonstrates how benefits outweigh risks in accordance with ISO 14971 and ISO 14155.

• E2b(R3) Electronic Reporting Support: Assisting firms in the transition to electronic transmission of safety data, ensuring compatibility with the VigiFlow and Med Safety App ecosystems.

• Benefit-Risk Synthesis: Robust medical evaluations that justify the safety profile of products within the South African clinical context, including specific data on local disease burdens (HIV/TB).

• Signal Detection & Analysis: Utilizing scientific methodologies to assess safety signals reported to the National Pharmacovigilance Steering Committee.

Why Pharma Leaders in South Africa Choose PSUR Central

"Scientific rigor for the continent’s most sophisticated and digitally-integrated regulatory environment."

• 2025 SAHPRA Portal Proficiency: We are fully operational within the new Engagement Portal, ensuring your safety updates, PSMFs, and resourcing information are submitted without technical friction.

• Global Reliance Specialist: We leverage SAHPRA's reliance pathways (Abridged and Verified Reviews) by aligning dossiers with EMA and US FDA standards to accelerate local approval times.

• Medical Device Maturity: We are experts in the December 2025 updates for medical devices, including the specific vigilance requirements for AI/ML-enabled technologies.

• 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:

• Medicines and Related Substances Act 101 of 1965 (Updated 2025): The primary legal pillar for health products in South Africa.

• SAHPGL-CEM-PV-04_v10: The 2025 updated guideline for Post-Marketing Reporting of Adverse Drug Reactions.

• National Health Product Vigilance Framework (2025): The roadmap for integrated vigilance in South Africa.

• 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 South Africa, we typically require:

1. Product Portfolio and registration status (NCE, Biological, Generic, or Medical Device).

2. Engagement Portal Access: Coordination info for your authorized HCR/LPO portal login.

3. Approved Labeling: The Professional Information (PI) and Patient Information Leaflet (PIL) as approved by SAHPRA.

4. Local vs. Global ADR Data: Summary of serious ICSRs reported via the Med Safety App or local spontaneous sources.

5. Submission Timeline: Coordination with your 5-year renewal or the specific data lock points (DLP) for your PBRER cycle.

Contact PSUR Central today to ensure your pharmaceutical safety compliance in South Africa is authority-ready and scientifically robust.

Global PSUR Compliance. Science-Driven. Authority-Ready.