On July 1, 2026, the Ministry of Health issued a synchronized set of three legal documents: Circular No. 26/2026/TT-BYT, Circular No. 27/2026/TT-BYT, and Circular No. 28/2026/TT-BYT. This regulatory framework standardizes the legal structure for classifying and controlling categories of medical products and goods under high and medium-risk levels within the management scope of the Ministry of Health.
1. Circular No. 26/2026/TT-BYT: List of medium-risk herbal materials and traditional medicines
The Circular provides a detailed list of herbal species, traditional ingredients, and finished traditional medicine formulations that carry a medium risk of error, contamination, or quality degradation across the supply chain (from harvesting, primary processing, and storage to distribution).
For objects in this category, regulatory authorities apply strict periodic quality control standards. The application of Good Storage Practices (GSP) and Good Distribution Practices (GDP) to this group requires close monitoring of microclimate conditions (temperature, humidity) to minimize the degradation of active pharmaceutical ingredients or the growth of fungi.
Significance: It guides healthcare facilities and enterprises to optimize focused testing operations, thereby reducing costs while ensuring the potency and safety of the preparations.
2. Circular No. 27/2026/TT-BYT: List of medium-risk food products; food utensils, and packaging materials in direct contact with food
The Circular clearly identifies groups of functional foods and dietary supplements (which closely border pharmaceuticals) along with utensils and plastic, metal, or glass packaging materials in direct contact with food.
The focus of Circular No. 27/2026/TT-BYT is to mandate manufacturing and importing organizations to demonstrate biological and chemical safety criteria. In particular, it limits heavy metal content, residual monomers, or plasticizers (such as phthalates) that may migrate from packaging into food under normal storage or high-temperature conditions.
Significance: It serves as the legal basis for the Pharmacy Department to collaborate with the Nutrition Department in controlling packaging-active ingredient interactions, ensuring the bioavailability of micronutrients supplied to inpatients.
3. Circular No. 28/2026/TT-BYT: List of high-risk and medium-risk chemical medicines, herbal medicines, vaccines, biologicals, pharmaceutical ingredients, semi-finished medicines, and semi-finished herbal materials
Risk Classification
- High risk: Drugs with a narrow therapeutic index, vaccines, biological products, toxic drugs, radiopharmaceuticals, ingredients highly susceptible to counterfeiting, or those requiring a cold chain.
- Medium risk: Common chemical medicines, and semi-finished medicines/herbal materials with moderate physicochemical stability.
For the high-risk group, comprehensive control is applied from pre-market (licensing, lot release) to post-market (distribution) stages. Pharmacovigilance and Adverse Drug Reaction (ADR) monitoring are significantly strengthened.
This list serves as the core basis for the hospital's Drug and Therapeutics Committee to formulate drug formularies, plan procurement bidding, and establish quarantine procedures to prevent medical adverse events.
Conclusion
The simultaneous issuance of Circulars 26, 27, and 28/2026/TT-BYT by the Ministry of Health demonstrates a powerful shift toward a modern, scientific, and transparent management model. By clearly defining risk levels (High and Medium), regulatory bodies and healthcare facilities can allocate resources optimally, focusing on critical points that pose the highest safety risks to patients.
Detailed document information: 26/2026/TT-BYT, 27/2026/TT-BYT, 28/2026/TT-BYT.
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