On the afternoon of April 21, 2026, the Ministry of Health held a pivotal meeting to discuss amendments to Circular 30/2025/TT-BYT. This move represents a strategic step in updating technical standards to align with pharmaceutical industry growth and international benchmarks.
Strategic Objectives of the Amendments
The regulatory adjustments aim beyond solving practical bottlenecks to achieve broader goals:
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International Alignment: Meeting rigorous World Health Organization (WHO) requirements for the National Regulatory Authority (NRA) for medicines and vaccines.
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Treatment Safety Optimization: Minimizing patient risks through stringent quality control from pre-market to post-market stages.
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Administrative Adaptation: Synchronizing regulations with new local government models and current legal frameworks.
Key Areas of Regulatory Focus
The drafting committee is prioritizing the clarification of concepts and the formalization of procedures for emerging practical issues:
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Strengthening Pre-market Testing: Clearer mandates for quality control before drugs reach the consumer.
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Streamlining Recall and Disposal: Enhancing the mechanism for handling sub-standard drugs based on sampling locations and ensuring environmentally safe disposal processes.
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Rapid Response Protocols: Immediate suspension of business, usage, and sealing of drug batches showing safety concerns.
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Enforcement on Supplementary Sampling: Establishing specific sanctions for manufacturers or importers that voluntarily recall products but fail to comply with subsequent supplementary sampling requests from health authorities.
Directive for Implementation
The Ministry of Health has directed the Drug Administration of Vietnam to collaborate with industry associations and medical experts to finalize the legal and technical aspects of the draft. The goal is to promptly issue a highly enforceable circular that supports pharmaceutical enterprise growth while maintaining a robust technical barrier to protect public health.