The Ministry of Health is officially gathering public feedback on a comprehensive draft Circular designed to govern the quality management of pharmaceutical drugs and active pharmaceutical ingredients (APIs). The regulatory framework proposes meticulous guidelines enforcing strict quality control parameters spanning upstream manufacturing and importation down to downstream circulation, wholesaling, retailing, and clinical utilization within Vietnam, covering chemical drugs, herbal medicines, vaccines, biologics, and raw materials (excluding crude herbal materials and traditional remedies).
The documented digitalization mandates for manufacturing/import facilities, the bi-level hierarchy of national inspection authorities, and risk-based sampling principles derived from WHO guidelines feature:
-
Digitalization Mandates and “Good Practice” Compliance for Manufacturing and Import Tiers:
-
Manufacturing and Compounding Sector: The draft mandate dictates that production facilities must strictly execute “Good Practice” (GPs) principles and parallel quality management systems to guarantee that finished product batches align perfectly with registries approved by the Ministry of Health. Manufacturers are legally ordered to deploy product labeling, advanced electronic labeling, or product digital passports, encoding full traceability data, identification numbers, and barcodes while archiving comprehensive testing profiles for post-market surveillance.
-
Importation Sector: Importing enterprises must maintain “Good Practice” metrics across importation, warehousing, and transit to insulate drug efficacy prior to patient delivery. Facilities are responsible for product registrations, electronic labeling/digital passport implementation, rigorous vendor evaluations, and absolute adherence to specialized import quality assurance statutes.
-
Distribution and Retail Logistics: Entities managing export, wholesale, retail, storage, and transport logistics must deploy technically qualified personnel, install specialized climate-controlled logistics hardware, maintain unified traceability ledger records, and submit to scheduled or unannounced state audits.
-
-
Bi-Level Hierarchy of State Quality Inspection Authorities and Sampling Regimes:
-
The draft Circular structurally uncouples the statutory state pharmaceutical inspection apparatus into two distinct administrative echelons:
-
Central Inspection Authority: The Drug Administration of Vietnam under the Ministry of Health, commanding supreme oversight and inter-agency coordination.
-
Local Inspection Authorities: Municipal and provincial Departments of Health.
-
-
Quality audits and monitoring sample extractions will be executed under the direct discretion of these inspection bodies via two mechanisms: pre-announced audits or unannounced surprise inspections. Periodic sampling blueprints will be constructed based on deep risk assessments and active market quality trends, pursuant to Decree No. 37/2026/NĐ-CP and institutional guidance formulated by the World Health Organization (WHO).
-
-
Annual Market Quality Survey Frameworks and Risk-Allocation Criteria:
-
Systemic market quality surveys targeting finished drugs and raw materials will be deployed annually, or triggered on an ad-hoc basis when qualitative anomalies, compromised safety indicators, or emergent bio-risks manifest. Regulatory assays must enforce standardized quality benchmarks and testing methodologies uniformly across identical drug classifications sharing equivalent active moieties and dosage forms.
-
The statutory selection matrix dictates that annual survey plans must heavily prioritize essential medicines, high-volume consumer drugs, and molecular compounds characterized by low chemical stability. The annual operational roadmap calculates multi-layered risk baselines tracking active drug stabilities, solubility/permeability variables, therapeutic windows, and historical adverse drug reaction (ADR) tracking datasets. The underlying survey sample sizes must guarantee statistical significance and geographical representation, strictly mirroring the epidemiological standards optimized by the WHO.
-
Source: https://baochinhphu.vn/quan-ly-chat-chat-luong-thuoc-nguyen-lieu-lam-thuoc-102260623144329422.htm