PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for the Lao Pharmaceutical Market: FDD | MoH | ASEAN | 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 and medical product landscape in Laos.
Laos is undergoing a significant regulatory transformation, with the Food and Drug Department (FDD) of the Ministry of Health (MoH) strengthening its post-marketing surveillance and pharmacovigilance (PV) systems. As a member of ASEAN, Laos is increasingly aligning with the ASEAN Common Technical Dossier (ACTD) and regional PV standards. In 2025, with the full implementation of phased medical device registration and the development of online registration systems, maintaining high-quality, internationally compliant safety documentation is a prerequisite for both domestic manufacturers and international importers.
Who We Support in Laos
We provide specialized pharmacovigilance expertise to the essential stakeholders of the Lao healthcare sector:
Pharmaceutical Import-Export Companies: Ensuring that medicines imported into the Lao market—particularly from regional leaders like Thailand, Vietnam, and China—are accompanied by "authority-ready" safety dossiers for FDD registration.
Domestic Manufacturers: Assisting Lao-based pharmaceutical factories in meeting GMP and safety monitoring standards as they expand their reach within the Mekong region.
Medical Device Operators: Managing the mandatory 2025 notification and registration requirements for Class A and B medical devices under the latest FDD strategic plan.
Health Supplement & Probiotic Producers: Navigating the 2025 updated framework for probiotic safety, functional claims, and technical characterization.
Local Authorized Representatives: Providing the technical back-end support required for local representatives to fulfill their legal duties under the Law on Drugs and Medical Products No. 07/NA.
Our PSUR & PBRER Services
Our scientific precision supports the FDD’s mission to ensure the quality, efficacy, and safety of all health products in Laos:
ASEAN-Aligned PBRER Preparation: Expert drafting in the ICH E2C (R2) format, ensuring seamless integration with ACTD Module 5 (Clinical Safety) for Lao product registrations.
Benefit-Risk Synthesis: High-level medical evaluations that move beyond simple data to provide a robust clinical defense of a product's safety profile for the FDD Drug Registration Committee.
Signal Detection & Management: Utilizing scientific methodologies to assess safety signals from global databases and local spontaneous reporting via the National Pharmacovigilance Centre.
Post-Market Surveillance Support: Helping firms comply with the FDD’s increasing focus on monitoring the safety and quality of marketed medicines in all provinces.
Lao Language Compliance Support: Assisting with the technical content required for Lao-version leaflets and labeling, ensuring that safety warnings and patient information are accurately translated.
Why Pharma Leaders in Laos Choose PSUR Central
"Scientific rigor for Laos’ modernizing and ASEAN-integrated pharmaceutical market."
2025 Regulatory Readiness: We are fully versed in the 2025 medical device notification schedule and the FDD's strategic shift toward online digital workflows.
ASEAN Harmonization Experts: Our reports bridge the gap between global ICH standards and the specific requirements of the ASEAN Pharmaceutical Product Working Group (PPWG).
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
Audit-Ready Documentation: Our reports have a 100% acceptance track record across global regulatory agencies (EMA, US FDA, ASEAN member states).
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Law on Drugs and Medical Products (No. 07/NA): The primary legal foundation for pharmaceutical activities in Laos.
Regulation on Drug Registration (No. 1441/MoH): The key framework for marketing authorization and lifecycle management.
ASEAN Common Technical Requirements (ACTR): The harmonized regional standards for pharmaceutical and supplement safety.
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 Laos, we typically require:
Product Portfolio and registration type (New Drug, Generic, or Health Supplement).
Approved Labeling: The SmPC (Summary of Product Characteristics) and Reference Safety Information (RSI).
Estimated Patient Exposure: Units sold or patient-years (Global and Laos-specific).
Summary of ICSRs: Line listings and tabulations from the FDD or your global safety database.
Submission Calendar: Coordination with your 3-year registration renewal cycles or specific FDD requests.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready