Pharmacovigilance

This section is a Vietnam-focused reference for pharmacovigilance (Cảnh giác Dược) — the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Scope: • Spontaneous adverse drug reaction (ADR) reporting at healthcare facilities, governed by Decision 29/QĐ-BYT (2022). • The National Guideline on Pharmacovigilance (Decision 122/QĐ-BYT, 2021), covering ADR monitoring across hospitals, herbal and traditional medicines, vaccination programmes, national health programmes, manufacturers and importers, and clinical trials. • Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs) as part of the marketing-authorization dossier under Circular 08/2022/TT-BYT. • Anaphylaxis prevention, diagnosis, and treatment under Circular 51/2017/TT-BYT, with mandatory reporting to the National or Regional DI & ADR Centre. • Adverse Events Following Immunization (AEFI) surveillance under Decree 104/2016/NĐ-CP and Circular 34/2018/TT-BYT. • Safety signal generation, DAV safety alerts, label changes, and product recalls. Vietnam joined the WHO Programme for International Drug Monitoring in 1999. The National Centre of Drug Information and Adverse Drug Reactions Monitoring (National DI & ADR Centre) at Hanoi University of Pharmacy, with the Regional Centre at Cho Ray Hospital in Ho Chi Minh City, operates the spontaneous reporting system; reports are submitted on paper or online via canhgiacduoc.org.vn (ADROnline).

Pharmacy Law: • Law on Pharmacy 105/2016/QH13 — sets the pharmacovigilance obligations of marketing-authorization holders and healthcare facilities. • Law 44/2024/QH15 — amends the Pharmacy Law (effective 1 July 2025); strengthens post-marketing safety obligations. National Pharmacovigilance guidelines: • Decision 122/QĐ-BYT — National Guideline on Pharmacovigilance, issued 11 January 2021. Replaces Decision 2111/QĐ-BYT (2015). Covers ADR monitoring at healthcare facilities, herbal and traditional medicines, vaccination systems, national health programmes, pharmaceutical companies, and clinical trials. • Decision 29/QĐ-BYT — Guideline on ADR Surveillance at Healthcare Facilities, issued 5 January 2022. Replaces Decision 1088/QĐ-BYT (2013). Defines who must report, what to report, and the workflow at clinical departments and the hospital Drug & Therapeutics Committee. • Decision 991/QĐ-BYT (24 March 2009) — established the National Centre of Drug Information and Adverse Drug Reactions Monitoring at Hanoi University of Pharmacy. Drug registration with PV obligations: • Circular 08/2022/TT-BYT — drug registration; sets out PSUR submission timelines and Risk Management Plan requirements as part of the dossier. Anaphylaxis: • Circular 51/2017/TT-BYT — issued 29 December 2017, effective 15 February 2018. Prevention, diagnosis, and treatment of anaphylaxis; classifies anaphylaxis into severity levels I–IV; mandates ADR reporting for every case. Vaccine safety / AEFI: • Decree 104/2016/NĐ-CP — issued 1 July 2016. Establishes immunization activities, including AEFI detection and management. • Circular 34/2018/TT-BYT — issued 16 November 2018, effective 1 January 2019. Implements Decree 104/2016 on vaccine receipt, transport, storage, immunization session organization, AEFI surveillance and root-cause investigation, and reporting procedures.

2025 — Strengthened post-marketing safety obligations: Law 44/2024/QH15 took effect on 1 July 2025, tightening pharmacovigilance obligations of marketing-authorization holders and aligning post-marketing safety requirements with ICH practice. 2022 — Updated hospital ADR surveillance guideline: Decision 29/QĐ-BYT (5 January 2022) replaced Decision 1088/QĐ-BYT (2013). Refined the reporting workflow, clarified roles within the Drug & Therapeutics Committee, and updated reporting forms. 2021 — Updated National Pharmacovigilance Guideline: Decision 122/QĐ-BYT (11 January 2021) replaced the 2015 Guideline (Decision 2111/QĐ-BYT). Expanded coverage of traditional medicines, biological products, and the Expanded Programme on Immunization (EPI). 2018–2019 — AEFI framework consolidated: Circular 34/2018/TT-BYT (16 November 2018, effective 1 January 2019) implemented Decree 104/2016/NĐ-CP on immunization, formalizing AEFI detection, root-cause investigation, and reporting at every vaccination site.