Pharmacovigilance obligations of drug manufacturers in Vietnam — what changes under Luật 44/2024 and Circular 12/2025

On 21 November 2024 the National Assembly passed Luật 44/2024/QH15, the first major amendment of the 2016 Pharmacy Law (Luật 105/2016/QH13). On 16 May 2025 the Ministry of Health issued Thông tư 12/2025/TT-BYT, the new circular on drug and active-ingredient registration that replaced the 2018/2022 framework. Both instruments took effect on the same day — 1 July 2025 — and together they redefine what a drug manufacturer (and the marketing-authorisation holder, "cơ sở đăng ký thuốc", that fronts it before DAV) must do to comply with Vietnam's pharmacovigilance regime. The 2021 National Pharmacovigilance Guideline issued under Quyết định 122/QĐ-BYT remains the technical reference for how those duties are operationalised in practice.

The statutory anchor — Article 77 of the Pharmacy Law

Pharmacovigilance ("cảnh giác dược") is defined in Article 2 of Luật Dược 2016 as the activity of detecting, evaluating and preventing harms associated with the use of medicines. Article 77 — sitting inside Chapter 8 on drug information, pharmacovigilance and advertising — distributes that activity across the system. The 44/2024 amendment did not rewrite Article 77 itself; what it did was reinforce, at the level of declared State policy, that pharmacovigilance and clinical-pharmacy practice are protected and developed.

Article 77, read with the new circular, sets up four streams of duty:

• Khoản 3 — healthcare professionals must actively monitor, evaluate, manage and report ADR signals to the competent authority. Hospitals route reports through their drug-information / pharmacovigilance units to the DI & ADR National Center in Hanoi or the DI & ADR Regional Center in Ho Chi Minh City.
• Khoản 4 — retail pharmacy operators must advise patients and report abnormal signals.
• Khoản 5 — and this is the manufacturer/MAH stream — production, compounding, processing and registration facilities must "organise monitoring" of the quality, safety and efficacy of their products throughout the post-authorisation life cycle, and "report and update information" to the competent authority.
• Khoản 6 — the Minister of Health retains the power to suspend the circulation of a drug when safety signals warrant it (Article 62 read with Article 77.6).

The drug-business circular — pharmacovigilance during introduction — is Thông tư 07/2018/TT-BYT (still in force as a guidance instrument under Decree 54/2017/NĐ-CP, with its drug-business sections amended by subsequent circulars). It tells pharmaceutical-business establishments that any ADR signal or quality concern collected during drug-introduction activities must be reported up to the Ministry of Health under the National Pharmacovigilance Guideline.

What is new — the manufacturer duties codified in Thông tư 12/2025/TT-BYT

Thông tư 12/2025/TT-BYT replaces the 2018-2022 line of drug-registration circulars (Thông tư 32/2018/TT-BYT, amended by Thông tư 08/2022/TT-BYT). It does not invent pharmacovigilance, but it consolidates and codifies — in articles directly addressed to the registering entity ("cơ sở đăng ký thuốc") and, by reference, to manufacturers — the operational obligations that follow from Article 77.5. Five obligations are now hard-coded:

1. Cooperative ADR monitoring (Article 3, clause 5). The MAH must cooperate with manufacturers, importers and distributors to monitor, collect, consolidate, evaluate and report cases of adverse reactions and post-vaccination events to the National DI & ADR Center, in accordance with the National Pharmacovigilance Guideline.

2. Periodic Safety Update Report (PSUR) — Article 10, with Form 2A/TT. For new chemical drugs, vaccines and biological products (probiotics excluded), the MAH must submit a PSUR every six months for the first two years from the date of the marketing-authorisation number ("số đăng ký lưu hành"); annually from year three to year five. The clock runs from the date the marketing-authorisation number is granted, not from first sale.

3. Individual Case Safety Reports (ICSR) — Article 10, with Form 2B/TT. The MAH must report all adverse events occurring in Vietnam — including ADRs in the classical sense, medication errors, suspected counterfeit or substandard products, and therapeutic failures. Reporting timelines (15 days, 7 days, or immediate, depending on seriousness and expectedness) are fixed by the National Pharmacovigilance Guideline issued under Quyết định 122/QĐ-BYT.

4. Risk Management Plan (RMP) — Articles 3.7, 4.6, 31.5, 38.4 and 39.3, with Form 03/TT. New chemical drugs, vaccines and biologicals must be registered with an approved RMP, including risk-mitigation measures and additional pharmacovigilance activities (registries, dedicated studies, healthcare-professional / patient communication). The MAH and the manufacturer must implement that plan throughout the validity period of the registration certificate.

5. Cross-border safety signal disclosure (Article 3, clause 3). The MAH must notify DAV in writing within 15 days of any decision in any country to revoke a marketing authorisation or to recall the product (in whole or in part), with reasons. Manufacturers similarly have a 15-day notification window under Article 4, clause 4 for licence revocation or GMP non-compliance findings.

How the National Pharmacovigilance Guideline (Quyết định 122/QĐ-BYT, 2021) operationalises this

The 2021 Guideline — a second-generation document that replaced Quyết định 2111/QĐ-BYT (2015) — is the technical reference that Thông tư 12/2025 keeps pointing back to. For manufacturers and MAHs, the operational content is concentrated in the chapter on pharmacovigilance at pharmaceutical-business units, with the following load-bearing rules:

• Designation of a pharmacovigilance lead inside the MAH organisation, with a documented role description and reporting line.
• Maintenance of a written Pharmacovigilance System Master File (PSMF) describing how ADR signals are detected, processed, evaluated and forwarded.
• Standard Operating Procedures for ICSR intake, follow-up and submission, with archiving (typically 10 years past expiry of the registration).
• Local reconciliation between the global database of the MNC parent and the Vietnamese pharmacovigilance file before each PSUR submission.
• Mandatory signal management — detection, prioritisation, validation, assessment, action — and pre-emptive communication to healthcare professionals when a safety signal becomes a regulatory action elsewhere.

In other words, an MAH that simply forwards what it receives from the field is non-compliant. The Guideline assumes an active pharmacovigilance function on Vietnamese soil — or, more commonly for foreign MAHs, an active local-representative function under a documented service agreement.

What the 44/2024 amendments change in the surrounding environment

Luật 44/2024/QH15 did not rewrite Article 77, but four amendments around it change the operational backdrop a manufacturer should plan against:

• E-commerce sale of medicines is now legalised on a controlled perimeter, which extends the reach of pharmacovigilance duties into platform operators and online-pharmacy aggregators — these will be brought into the ADR-flow obligations by the implementing decree (a draft of which was circulated by DAV on 9 January 2025).
• Pharmacy-chain models are recognised as a unified quality-managed entity, which means a chain-wide ADR intake mechanism is now a contemplated structure.
• Foreign-invested manufacturers and importers have their distribution and direct-supply rights clarified — and with those rights, the pharmacovigilance flow that previously routed through a Vietnamese intermediary may now sit directly with the foreign-invested entity.
• Priority registration procedures for new drugs, first-domestic generics, vaccines and orphan drugs are accompanied by a tightened RMP expectation: the regulator's willingness to shorten the front end of the lifecycle is paired with a heavier post-market obligation.

The reporting channels and forms — practical map

Under Thông tư 12/2025 read with the 2021 Guideline, the operational endpoints are:

• National DI & ADR Center, Hanoi (Trung tâm Quốc gia về Thông tin thuốc và Theo dõi phản ứng có hại của thuốc) — primary recipient for the northern provinces and for PSURs irrespective of region.
• DI & ADR Regional Center, Ho Chi Minh City — primary recipient for the southern provinces.
• DAV (Drug Administration of Vietnam) — recipient for the cross-border safety-signal notifications under Article 3.3, and for the licence/GMP findings under Article 4.4.
• Form 2A/TT — PSUR template.
• Form 2B/TT — ICSR template.
• Form 03/TT — RMP template.

What manufacturers operating in Vietnam should be doing now

The 1 July 2025 effective date is past. The grace window the regulator used during the previous regime — where late or thin PSURs were tolerated for foreign-invested MAHs — has narrowed materially, and DAV inspections in the second half of 2025 already returned a non-trivial number of administrative findings tied to PSUR cadence and RMP implementation lag.

• Re-baseline the PSUR schedule against the date on the marketing-authorisation number, not against any internal anniversary; build a Q1/Q3 (or Q2/Q4) submission calendar that survives staff turnover.
• Re-paper the local pharmacovigilance arrangement. If the function sits with a local representative under an MAH agreement, make sure the agreement is current, signed, names the Qualified Person for Pharmacovigilance (QPPV) at the Vietnamese end, and is reflected in the registration dossier.
• Run a gap analysis against the 2021 Guideline — PSMF, SOPs, archive duration, signal-management workflow, healthcare-professional communication plan. Findings here are the cheapest to remediate.
• Update the RMP. Any "new chemical drug, vaccine or biological" registration whose RMP was approved under the 2018/2022 regime should be cross-referenced against Form 03/TT and Articles 3.7 / 4.6 / 31.5 / 38.4 / 39.3 of Thông tư 12/2025. Mark which risk-mitigation measures are still "promised" but not implemented.
• Wire the global-to-local reconciliation. The 15-day notification window for foreign revocation / recall decisions under Article 3.3 only works if the global safety team feeds the Vietnamese pharmacovigilance lead within 48–72 hours of the foreign action.
• Plan for e-commerce. Where the manufacturer's products move through online pharmacies or platforms, ensure that ADR-intake URLs and contact points on platform product pages route into the same MAH workflow — the implementing decree under Luật 44/2024 will not treat the online channel as a side stream.

The interpretive direction of travel — closer to ICH/EMA, with a Vietnamese floor

Read together, Luật 44/2024, Thông tư 12/2025 and the 2021 Guideline move Vietnam closer to the ICH E2A / E2D / E2E vocabulary on individual case reporting, periodic safety reporting and pharmacovigilance planning. The convergence is partial — the Vietnamese regime still treats medication errors, suspected counterfeits and therapeutic failures as in-scope for the same ICSR funnel, and it keeps a domestic post-market clock (2 years semi-annual, then annual to year 5) rather than the ICH PSUR rhythm in the strict sense. For a manufacturer running a multi-country pharmacovigilance system, the practical answer is to map the Vietnamese requirement as an additional rather than a substitute layer.

The expectation in 2026 is that the implementing decree under Luật 44/2024 — circulated as a draft on 9 January 2025 by DAV — will be issued in final form, and that DAV will publish, through canhgiacduoc.org.vn and dav.gov.vn, a refreshed set of FAQs that clarify the e-commerce channel, the pharmacy-chain ADR-intake model, and the foreign-invested MAH structures. Manufacturers should track those two domains as the canonical channel for technical clarifications.

Sources

• Văn phòng Quốc hội — Luật Dược 105/2016/QH13 (Article 77 — Cảnh giác dược) and Luật 44/2024/QH15 (effective 1 July 2025).
• Văn bản hợp nhất 39/VBHN-VPQH (2025) and 76/VBHN-VPQH (2026) — consolidated text of the Pharmacy Law as amended.
• Bộ Y tế — Thông tư 12/2025/TT-BYT (16 May 2025; effective 1 July 2025) on drug and drug-material registration.
• Bộ Y tế — Thông tư 07/2018/TT-BYT on drug-business activities (in force, amended by subsequent circulars).
• Bộ Y tế — Quyết định 122/QĐ-BYT (11 January 2021) issuing the National Pharmacovigilance Guideline (replacing Quyết định 2111/QĐ-BYT, 2015).
• Cục Quản lý Dược (DAV) — draft implementing decree under Luật 44/2024, circulated 9 January 2025.
• Trung tâm Quốc gia về Thông tin thuốc và Theo dõi phản ứng có hại của thuốc (canhgiacduoc.org.vn) — coverage of Thông tư 12/2025/TT-BYT.
• LuatVietnam — analytical summary of Thông tư 12/2025/TT-BYT and "7 điểm mới tại Luật Dược sửa đổi 2024".
• ThuVienPhapLuat — full text of Luật 44/2024/QH15 and Thông tư 12/2025/TT-BYT.
• Dione — "Circular No. 12/2025/TT-BYT comes into force from July 01, 2025".
• Lexology — Q&A on marketing authorisation for pharmaceuticals in Vietnam.