DDReg Pharma

Pharmacovigilance Services in Vietnam

The National Center of Drug Information and Adverse Drug Reactions Monitoring centre (NDIADRMC) of the Ministry of Health (MOH) is responsible for pharmacovigilance activities in Vietnam. This centre carries out the administrative functions of collecting, analyzing, and evaluating the adverse events 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 ADR 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, a Periodic Benefit Risk Evaluation Report, or a Safety Report along with a summary safety report in the Vietnamese language including details of both foreign and domestic 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, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.
DDReg pharmacovigilance Services portfolio include:
ICSR Processing and Submission
Risk Management Plan
Aggregate Reports
Signal Management
PV Services
PV Audit & Compliance
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