Pharmacovigilance Services in Vietnam

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Vietnam, explore DDReg’s pharmacovigilance services in Vietnam to ensure drug safety and regulatory compliance. From adverse drug reaction reporting to compliance with NDIADRMC pharmacovigilance regulations, the right PV partner shapes everything including signal detection, risk management planning, safety reporting, and successful market authorization.

Expert Pharmacovigilance Services for the Vietnam Market

The National Centre of Drug Information and Adverse Drug Reactions Monitoring Centre (NDIADRMC) of the Ministry of Health (MOH) is responsible for pharmacovigilance services in Vietnam. This centre carries out the administrative functions of collecting, analyzing, and evaluating adverse event reports from various sources and updating the PV database. It also assesses the benefit-risk balance and communicates drug-related risks. Until now, NDIADRMC has been focusing on reporting adverse drug reactions (ADRs) from healthcare professionals, national public health programs, and pharmaceutical companies to avoid misleading information from consumers and community pharmacists. In addition, pharmaceutical companies are required to submit a Periodic Safety Update Report (PSUR ), a Periodic Benefit-Risk Evaluation Report (PBRER), or a Safety Report along with a summary safety report in the Vietnamese language, including details of both foreign and domestic Individual Case Safety Reports (ICSRs). ADRs can be reported online through the official NDIADRMC website specially deployed for ADR reporting.

As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Vietnam that include adverse drug reaction reporting, signal detection & management, aggregate report writing, and development of customized pharmacovigilance plans/risk management plans in accordance with local requirements and good pharmacovigilance practices.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Case processing through E2B(R3) compliant databases and other relevant databases integrated with drug dictionaries (WHO DD) and MedDRA
  • Quality check, medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR monitoring & tracking sheets
  • Reconciliation process with customers
• + Risk Management Plan (RMP)
  • Drafting, reviewing, and maintaining Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies ( REMS) while providing support through submission methods
  • Preparing customized procedures to classify safety risks and deliver tailored risk management strategies
  • Assessment of potential risks and missing information and preparation of reports that recommend risk management methods
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), such as developing academic materials, observational examinations, and targeted follow-up questionnaires
  • Effectively convey risks through labeling documents – i.e., Prescribing Information & Medical Guides (PIL)
• + Aggregate Reports
  • Periodic Safety Update Report (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Identification of new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, literature, aggregate reports, as well as regulatory agency website monitoring
  • Utilizes a variety of in-house tools and databases for signal detection and tracking signal management processes
  • Reviews safety signals for ICSRs, aggregate reports, and recommendations by Pharmacovigilance Risk Assessment Committee (PRAC)
  • Performs label update analysis
  • Provide recommendations from signal assessments, which include risk minimization approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports
• + Qualified Person for Pharmacovigilance (QPPV)
  • Review of Pharmacovigilance System Master File (PSMF), Safety Data Exchange Agreements (SDEAs), agreements with commercial partners, Pharmacovigilance Standard Operating Procedures (SOPs), etc.
  • Retainer services for QPPV Services and Deputy
  • Local Safety Responsible
  • Monthly reconciliation
  • Medical review of signal detection; Signal Surveillance Meetings (Quarterly)
  • Monthly communication report/provision of compliance metrics
  • Pharmacovigilance Quality Management System Oversight
• + Pharmacovigilance Audit & Compliance
  • Review audit and compliance to applicable pharmacovigilance guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (Standard Operating Procedures), and work instructions
  • Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for pharmacovigilance inspections conducted by respective competent authorities
  • Conduct regular gap assessments of pharmacovigilance staff at site locations
  • Provide organizational training on safety audits and inspections