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Introduction of a Preventive Solution Against Respiratory Syncytial Virus (RSV) in Vietnam

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Introduction of a Preventive Solution Against Respiratory Syncytial Virus (RSV) in Vietnam

On December 14, a major vaccination system in Vietnam officially introduced and began administering the Respiratory Syncytial Virus (RSV) vaccine from the British pharmaceutical manufacturer, GSK. This deployment comes as deteriorating air quality in many urban areas elevates the risk of respiratory diseases among the adult population.

The vaccine rollout realizes a strategic cooperation agreement between the vaccination provider and GSK, an agreement that was signed in London just two months prior. The initial vaccine batches have been transported and stored in cold chain systems that meet international Good Storage Practice (GSP) standards.

Vaccine Details and Public Health Impact

This vaccine product was specifically developed for the demographic aged 60 and older and individuals suffering from chronic illnesses. The vaccine functions by utilizing a specific RSV virus protein, combined with an enhancing adjuvant. This mechanism is designed to generate an optimal immune response, helping older individuals—even those with frail health or underlying conditions—recognize and fight the virus effectively and sustainably.

Clinical data indicates the vaccine achieves an efficacy rate of nearly 95% in older adults with pre-existing health conditions. The solution has been approved in nearly 70 countries and has seen over 10 million doses administered globally. In Vietnam, specialized medical organizations focused on Cardiology and Respiratory Medicine have recommended RSV vaccination as an integral part of the management strategy for prevalent chronic diseases such as Chronic Obstructive Pulmonary Disease (COPD) and heart failure.

Burden of Disease Requiring Control

The RSV virus is identified as a primary agent causing severe respiratory conditions, including pneumonia and respiratory failure across all age groups, posing a particularly high risk to the elderly. In this demographic, RSV can lead to critical complications, exacerbate existing health issues, and increase the risk of dangerous cardiovascular events such as stroke or myocardial infarction, potentially resulting in death.

Statistics show that the disease burden caused by RSV in Vietnam is significant. It is estimated that over a five-year period, the virus may have caused approximately 4.6 million infections, 200,000 hospitalizations, and 18,000 deaths in the over-60 age group.

Medical experts state that there is currently no specific treatment for RSV. Therefore, active prevention through vaccination plays an especially crucial role. The vaccine, administered as a single dose, is considered a simple, effective measure to help reduce the risk of hospitalization, severe complications, and alleviate strain on the healthcare system.

Source: https://suckhoedoisong.vn/vnvc-ra-mat-vac-xin-rsv-the-he-moi-phong-viem-phoi-cho-nguoi-lon-khi-o-nhiem-gia-tang-169251215082349168.htm

Regulatory Update: Decision No. 629/QĐ-QLD on Renewing Marketing Authorization for Vaccines and Biological Products

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Regulatory Update: Decision No. 629/QĐ-QLD on Renewing Marketing Authorization for Vaccines and Biological Products

Decision No. 629/QĐ-QLD, issued by the Drug Administration of Vietnam (DAV) on October 31, 2025, officially announces the list of 05 Vaccines and Biological Products (vắc xin, sinh phẩm) that have been successfully renewed their Marketing Authorization Certificates (Giấy đăng ký lưu hành) in Vietnam. This public announcement ensures the continued legal importation, circulation, and supply of these essential products within the Vietnamese market.

Key Highlights

  • Scope of Application: The Decision applies to the manufacturers, registration holders, and distribution channels for the 05 specific vaccines and biological products listed, allowing their continued legal business operations in Vietnam.
  • Key Updates/Content:
    • List of Products: The core content is the appended list detailing the trade name, active ingredients (hoạt chất), strength (hàm lượng), dosage form (dạng bào chế), packaging (quy cách đóng gói), manufacturer, and registration number of the 05 approved vaccines and biological products. Ví dụ, các sản phẩm Lomoh 40 và Enoxaparin natri được gia hạn.
    • Legal Basis: The decision is based on the Law on Pharmacy and related decrees, including Decree No. 163/2025/NĐ-CP (chi tiết thi hành Luật Dược) and Decree No. 42/2025/NĐ-CP (quy định chức năng của Bộ Y tế).

  • Effective Date: The Decision takes effect from the date of signing (October 31, 2025).

  • This summary is provided for reference purposes only and highlights key aspects of Decision No. 629/QĐ-QLD. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Decision No. 629/QĐ-QLD 2025 (Official PDF – signed & sealed)

Regulatory Update: Decision No. 359/QĐ-QLD on Issuing a List of Foreign Drugs Approved for Marketing Authorization

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Regulatory Update: Decision No. 359/QĐ-QLD on Issuing a List of Foreign Drugs Approved for Marketing Authorization

Decision No. 359/QĐ-QLD, issued by the Drug Administration of Vietnam (DAV) on July 17, 2025, officially announces the list of 103 foreign-manufactured drugs that have been successfully granted or renewed their Marketing Authorization Certificates (Giấy đăng ký lưu hành) in Vietnam. This public announcement ensures that these drugs can be legally imported, circulated, and supplied within the Vietnamese market.

Key Highlights

  • Scope of Application: The Decision directly impacts pharmaceutical companies, importers, and distributors, allowing the legal circulation of the newly registered or renewed drugs listed in the accompanying annex.
  • Key Updates/Content:
    • List of Drugs: The core content is the appended list detailing the trade name, active ingredients (hoạt chất), strength (hàm lượng), dosage form (dạng bào chế), packaging (quy cách đóng gói), manufacturer, shelf life (Hạn dùng), and registration number of the 103 approved foreign drugs.
    • Legal Basis: The decision is based on the Law on Pharmacy and several related decrees, including Decree No. 163/2025/NĐ-CP (chi tiết thi hành Luật Dược) and Decree No. 42/2025/NĐ-CP (quy định chức năng của Bộ Y tế).
    • Effective Date: The Decision takes effect from the date of signing (July 17, 2025).

  • Compliance Obligation: Concerned organizations are responsible for complying with all relevant regulations regarding drug registration, distribution, quality, advertising, and price management.

This summary is provided for reference purposes only and highlights key aspects of Decision No. 359/QĐ-QLD. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Decision No. 359/QĐ-QLD 2025 (Official PDF – signed & sealed)

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Regulatory Update: Circular No. 30/2025/TT-BYT on Quality Standards, Testing, and Recall of Drugs

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Regulatory Update: Circular No. 30/2025/TT-BYT on Quality Standards, Testing, and Recall of Drugs

Circular No. 30/2025/TT-BYT, issued by the Ministry of Health on July 01, 2025, provides detailed instructions for applying quality standards, testing, and managing the recall and disposal of non-compliant drugs and raw materials. Ban hành dựa trên Luật Dược và Nghị định 163/2025/NĐ-CP, Thông tư này nhằm đảm bảo chất lượng và an toàn của các sản phẩm dược phẩm lưu hành trên thị trường, đồng thời chuẩn hóa quy trình xử lý các vi phạm.

Key Highlights

  • Scope of Application: The Circular guides the detailed application of quality standards for drugs (chemical, herbal, vaccines, bio-products) and raw materials (trừ dược liệu và bán thành phẩm dược liệu), procedures for drug testing, and the process for recalling and handling defective drugs and raw materials.
  • Key Updates/Content:
    • Quality Standards: Specifies the hierarchy and application of quality standards, prioritizing the Vietnamese Pharmacopoeia (Dược điển Việt Nam) or recognized foreign pharmacopoeia, or registered manufacturing standards.
    • Drug Inspection and Testing: Outlines the role and responsibilities of state drug testing agencies in conducting quality inspections and testing of drugs and raw materials, especially for imported batches.
    • Drug Recall (Thu Hồi): Details the levels of compulsory recall (mức độ thu hồi) and the responsibilities of registration holders, manufacturers, and distributors in executing a recall, as well as the reporting requirements to competent authorities.
    • Handling Violations: Provides guidance on the destruction and disposal of non-compliant drugs, including specific financial responsibilities (e.g., refunding sampling fees/testing costs for non-compliant samples).

This summary is provided for reference purposes only and highlights key aspects of Circular No. 30/2025/TT-BYT. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Circular No. 30/2025/TT-BYT (Official PDF – signed & sealed)

Regulatory Update: Circular No. 28/2025/TT-BYT on Procedures for Drug Registration (Marketing Authorization)

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Regulatory Update: Circular No. 28/2025/TT-BYT on Procedures for Drug Registration (Marketing Authorization)

Circular No. 28/2025/TT-BYT, issued by the Ministry of Health on July 10, 2025, sets forth comprehensive regulations concerning the dossiers and procedures for applying for, re-issuing, renewing, modifying, supplementing, and revoking Drug Registration Certificates (Giấy đăng ký lưu hành thuốc). This Circular is essential for pharmaceutical manufacturers and importers, providing the legal framework for bringing new and existing drugs and medicinal raw materials into the Vietnamese market.

Key Highlights

  • Scope of Application: The Circular applies to domestic and foreign organizations and individuals involved in the filing and application processes related to the registration of drugs (finished products) and raw materials for medicine production (nguyên liệu làm thuốc) in Vietnam.
  • Key Updates/Content:
    • Dossier Structure: Specifies the detailed required documentation (Hồ sơ) for initial applications, renewals, and modifications, often based on the Common Technical Document (CTD) or ASEAN Common Technical Dossier (ACTD) format.
    • Review Procedures & Timeline: Outlines the sequence of application review, expert consultation, and approval process, along with specific timeframes for competent agencies (Bộ Y tế/Cục Quản lý Dược) to process and respond to applications.
    • Changes and Supplements: Clarifies the categorization of changes (major/minor) to a registered drug and the corresponding application requirements for approval (thay đổi, bổ sung).
    • Renewal and Revocation: Details the necessary steps and supporting documents required for renewing an expiring registration and the grounds for compulsory or voluntary revocation of a registration certificate.

This summary is provided for reference purposes only and highlights key aspects of Circular No. 28/2025/TT-BYT. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Circular No. 28/2025/TT-BYT (Official PDF – signed & sealed)

 

Regulatory Update: Circular No. 31/2025/TT-BYT on Drug Labeling and Package Inserts

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Regulatory Update: Circular No. 31/2025/TT-BYT on Drug Labeling and Package Inserts

Circular No. 31/2025/TT-BYT, issued by the Ministry of Health on August 15, 2025, provides comprehensive regulations on the content and presentation of drug labeling and package inserts (Patient Information Leaflets). The Circular aims to ensure that medicines circulated in Vietnam carry accurate, complete, and legally compliant information, facilitating safe and effective use by both healthcare professionals and patients.

Key Highlights

  • Scope of Application: The Circular applies to organizations and individuals involved in the production, processing, import, export, or distribution of medicines in Vietnam, ensuring compliance with labeling standards for both domestically manufactured and imported drugs.
  • Key Updates/Content:
    • Mandatory Label Content: Details the specific information required on primary and secondary drug packaging, including dosage form, active ingredients, excipients (tá dược), manufacturer/importer information, batch number, expiry date, and warning symbols.
    • Package Insert (Tờ Hướng Dẫn Sử Dụng Thuốc): Stipulates the detailed structure and mandatory information for patient information leaflets, such as indications, contraindications, dosage, administration, side effects, and storage conditions.
    • Language and Format: Specifies the language requirements (Vietnamese is mandatory) and standards for font size, clarity, and durability of labeling materials.
    • Special Drug Labeling: Includes provisions for specific types of drugs, such as controlled substances or vaccines, requiring additional information or warning statements.

This summary is provided for reference purposes only and highlights key aspects of Circular No. 31/2025/TT-BYT. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Circular No. 31/2025/TT-BYT (Official PDF – signed & sealed)

Regulatory Update: Law No. 74/2024/QH15 on Environmental Protection Tax

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Regulatory Update: Law No. 74/2024/QH15 on Environmental Protection Tax

Law No. 74/2024/QH15, passed by the National Assembly on December 20, 2024, is the new governing law for Environmental Protection Tax (EPT/Thuế BVMT) in Vietnam. This Law regulates the determination of taxable objects, non-taxable objects, taxpayers, tax base (quantity of goods subject to tax), tax rates, and policies for EPT exemption and reduction, aiming to incentivize environmentally friendly production and consumption.

Key Highlights

  • Scope of Application: EPT applies to goods and services whose usage causes negative impacts on the environment, including gasoline, coal, and certain chemicals.
  • Key Updates/Content:
    • Taxable Objects: Details the list of goods (sản phẩm) and services subject to EPT, typically levied on specific quantities of products consumed or sold.
    • Tax Rates (Mức Thuế): Specifies the fixed tax amount per unit (VND/kg or VND/liter) for each taxable product (e.g., gasoline, coal, plastic bags), which is determined by the National Assembly Standing Committee.
    • Tax Exemption/Reduction: Outlines the conditions for EPT exemptions and reductions, often applied to goods temporarily imported/re-exported or in cases of force majeure.
    • Taxpayer: Identifies organizations and individuals who produce, import, or trade in EPT-taxable goods as the key taxpayers.

This summary is provided for reference purposes only and highlights key aspects of Law No. 74/2024/QH15. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Law No: 74/2024/QH15 (Official PDF – signed & sealed)

Regulatory Update: Decree No. 219/2025/NĐ-CP on Detailed Regulations for Implementing the Law on Export Tax and Import Tax

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Regulatory Update: Decree No. 219/2025/NĐ-CP on Detailed Regulations for Implementing the Law on Export Tax and Import Tax

Decree No. 219/2025/NĐ-CP, issued by the Government on August 15, 2025, provides detailed regulations and guidance for implementing the Law on Export Tax and Import Tax. The Decree aims to clarify the scope of goods subject to export/import duties, detail the method for determining the taxable price and tax rates, and establish the specific conditions and procedures for applying duty exemption, reduction, and refund policies.

Key Highlights

  • Scope of Application: The Decree guides the detailed implementation of the Law on Export Tax and Import Tax, covering the determination of duty-taxable objects, non-taxable objects, tax base (giá tính thuế), tax rates, and tax management procedures.
  • Key Updates/Content:
    • Taxable Goods: Details goods subject to export duty and imported goods subject to import duty.
    • Taxable Price (Giá Tính Thuế): Stipulates the principles and methods for determining the taxable price for exported goods and imported goods, aligned with customs valuation principles.
    • Duty Exemption/Reduction: Specifies cases eligible for tax exemption or reduction, including goods imported for processing, raw materials for export production, and specialized machinery/equipment used for scientific research or specific investment projects.
    • Procedures: Provides administrative procedures related to duty declaration, payment, reduction, exemption, and refund.

This summary is provided for reference purposes only and highlights key aspects of Decree No. 219/2025/NĐ-CP. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Decree No. 219/2025/NĐ-CP (Official PDF – signed & sealed)

Regulatory Update: Decree No. 293/2025/NĐ-CP on Detailed Regulations for Implementing the Law on Corporate Income Tax (CIT)

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Regulatory Update: Decree No. 293/2025/NĐ-CP on Detailed Regulations for Implementing the Law on Corporate Income Tax (CIT)

Decree No. 293/2025/NĐ-CP, issued by the Government on November 28, 2025, provides detailed regulations and guidance for implementing the Law on Corporate Income Tax (CIT/TNDN). The Decree aims to clarify the determination of CIT taxable income, detail the conditions for deductible expenses (expenses allowed to be subtracted for tax calculation), stipulate CIT incentives, and guide the procedures for CIT declaration and payment.

Key Highlights

  • Scope of Application: The Decree guides the detailed implementation of the Law on CIT, applying to all organizations engaged in the production and trading of goods and services, and having income subject to CIT in Vietnam.
  • Key Updates/Content:
    • Taxable Income: Details the scope of taxable income, including income from business activities, capital transfers, real estate transfers, and income generated from abroad.
    • Deductible Expenses: Clarifies the specific conditions and limits for expenses that are deductible (such as salary, interest, depreciation, and marketing costs) when calculating net taxable income.
    • CIT Incentives: Specifies conditions for applying CIT incentives, including reduced tax rates (e.g., 10%, 15%, 17%) and tax exemption/reduction periods, typically applicable to high-tech, large-scale manufacturing, or investments in disadvantaged areas.
    • Tax Base Calculation: Provides detailed rules for calculating CIT obligations, including treatment of losses carried forward and accounting for expenses not subject to CIT.

This summary is provided for reference purposes only and highlights key aspects of Decree No. 293/2025/NĐ-CP. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Decree No. 293/2025/NĐ-CP (Official PDF – signed & sealed)

Regulatory Update: Decree No. 310/2025/NĐ-CP on Detailed Regulations for Implementing the Law on Personal Income Tax (PIT)

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Regulatory Update: Decree No. 310/2025/NĐ-CP on Detailed Regulations for Implementing the Law on Personal Income Tax (PIT)

Decree No. 310/2025/NĐ-CP, issued by the Government on December 15, 2025, provides detailed regulations and guidance for implementing the Law on Personal Income Tax (PIT/TNCN). The Decree aims to clarify and detail various aspects of PIT, including defining different categories of taxable income, specifying the calculation of tax deductions (such as family circumstance deduction), and setting out the administrative procedures for tax declaration, withholding, and annual PIT finalization.

Key Highlights

  • Scope of Application: The Decree guides the detailed implementation of the Law on PIT, encompassing taxable incomes, tax-exempt incomes, tax bases, tax rates, tax calculation methods, and PIT finalization and refund procedures.
  • Key Updates/Content:
    • Taxable Income Categories: Details what constitutes income from business activities, wages/salaries, capital investment, capital transfer, real estate transfer, and other taxable sources.
    • Family Circumstance Deduction (Giảm Trừ Gia Cảnh): Specifies the standard deduction levels for the taxpayer and for each dependent, and outlines the procedures for registration and substantiation of dependents.
    • Tax Rates and Calculation: Clarifies the progressive tax schedule applicable to income from business and salary/wages, and the fixed rates for other income types.
    • Compliance Procedures: Provides rules on the responsibilities of income-paying organizations/individuals regarding tax withholding and filing annual tax finalization on behalf of individuals.

This summary is provided for reference purposes only and highlights key aspects of Decree No. 310/2025/NĐ-CP. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Decree No. 310/2025/NĐ-CP (Official PDF – signed & sealed)

Regulatory Update: Decree No. 174/2025/NĐ-CP on Detailed Regulations for Implementing the Law on Special Consumption Tax

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Regulatory Update: Decree No. 174/2025/NĐ-CP on Detailed Regulations for Implementing the Law on Special Consumption Tax

Decree No. 174/2025/NĐ-CP, issued by the Government on July 15, 2025, provides detailed regulations for implementing the Law on Special Consumption Tax (TTĐB). The Decree aims to clarify the scope of goods and services subject to TTĐB, stipulate detailed methods for calculating the taxable price (giá tính thuế), and establish procedures for implementing TTĐB exemption, reduction, and refund policies for businesses and importers.

Key Highlights

  • Scope of Application: The Decree governs detailed implementation measures for the Law on Special Consumption Tax, including defining taxable objects, non-taxable objects, taxpayers, and tax calculation methods.
  • Key Updates/Content:
    • Taxable Objects: Clarifies goods and services subject to TTĐB, such as alcohol, beer, tobacco, cars, gasoline, and certain luxury/gaming services.
    • Taxable Price Calculation: Provides specific formulas and bases for determining the taxable price for domestic production, importation, and in cases where the selling price is below the statutory price set by the Ministry of Finance.
    • Tax Exemption/Refund: Details procedures for tax exemption/reduction for certain domestic production inputs and tax refunds for exported goods or those brought temporarily into Vietnam for re-export (tạm nhập tái xuất).

This summary is provided for reference purposes only and highlights key aspects of Decree No. 174/2025/NĐ-CP. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Decree No. 174/2025/NĐ-CP (Official PDF – signed & sealed)

Regulatory Update: Circular No. 69/2025/TT-BTC on Detailed Guidance for Value-Added Tax (VAT)

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Regulatory Update: Circular No. 69/2025/TT-BTC on Detailed Guidance for Value-Added Tax (VAT)

Circular No. 69/2025/TT-BTC, issued by the Ministry of Finance on July 01, 2025, provides detailed guidance for implementing the new Law on VAT (Law 48/2024/QH15) and Decree 181/2025/NĐ-CP. This Circular clarifies specific conditions for VAT exemptions, defines the procedures for input VAT credit, and details documentation requirements for VAT refunds, ensuring consistent application across the country.

Key Highlights

  • Scope of Application: The Circular guides the detailed implementation of regulations regarding VAT taxable objects, non-taxable objects, VAT calculation methods, tax rates, input VAT deduction, and VAT refunds.
  • Key Updates/Guidance:
    • Non-Taxable Objects: Provides clear definitions and conditions for goods and services specified as VAT-exempt, particularly for agricultural products, medical/veterinary services, and certain specialized equipment.
    • Tax Rates (0%, 5%, 10%): Reaffirms the application of the three tax rates and provides specific examples and conditions for when the 0% rate applies (e.g., exports, international transport).
    • Input VAT Deduction: Details the conditions for claiming Input VAT credit, including:
      • Documentation requirements (Valid VAT invoices).
      • Rules for separating deductible and non-deductible input VAT when used for both taxable and non-taxable activities.
      • VAT Refund Procedures: Provides detailed guidance on the conditions and procedures for VAT refunds, including the minimum threshold for claiming a refund (e.g., at least 300 million VND of accumulated deductible input VAT).
  • Effective Date: The Circular is effective from July 01, 2025, aligning with the effective date of the new VAT Law.

This summary is provided for reference purposes only and highlights key aspects of Circular No. 69/2025/TT-BTC. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Circular No. 69/2025/TT-BTC (Official PDF – signed & sealed)

Regulatory Update: Decree No. 181/2025/NĐ-CP on Detailed Regulations and Guidance for Implementing the Law on Identity

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Regulatory Update: Decree No. 181/2025/NĐ-CP on Detailed Regulations and Guidance for Implementing the Law on Identity

Decree No. 181/2025/NĐ-CP, issued by the Government on July 22, 2025, provides detailed regulations and guidance for implementing several articles of the Law on Identity (Luật Căn cước). The Decree focuses on managing citizen identity information, issuing and using the Identity Card, and establishing administrative procedures related to national identity database management.

Key Highlights

  • Scope of Application: The Decree governs detailed content and measures to guide the implementation of the Law on Identity.
  • Key Updates/Content:
    • Details the establishment and management of the National Identity Database.
    • Specifies procedures for issuing, renewing, and revoking the Identity Card.
    • Regulates the use and confirmation of personal identification information.
    • Outlines the rights and responsibilities of agencies, organizations, and individuals in the exploitation and use of identity information.

This summary is provided for reference purposes only and highlights key aspects of Decree No. 181/2025/NĐ-CP. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Decree No. 181/2025/NĐ-CP (Official PDF – signed & sealed)

Regulatory Update: Law No. 48/2024/QH15 on Value-Added Tax (VAT)

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Regulatory Update: Law No. 48/2024/QH15 on Value-Added Tax (VAT)

Law No. 48/2024/QH15 on VAT, passed by the National Assembly on November 26, 2024, is the new governing law for Value-Added Tax in Vietnam. This law consolidates regulations on taxable objects, tax rates, tax calculation methods, tax credits, and VAT refunds. Notably, it clarifies VAT obligations for foreign suppliers involved in e-commerce and digital platforms, and updates rules on non-taxable activities. 

Key Highlights

  • Scope of Application:
    • Goods and services used for production, business, and consumption in Vietnam are generally subject to VAT.
    • Taxpayers include businesses producing/trading taxable goods/services, importers, and foreign organizations/individuals supplying services to Vietnam (including via e-commerce/digital platforms).
  • Key Updates (Taxable/Non-Taxable & Rates):
    • Non-Taxable (VAT Exemptions – Điều 5): Includes certain raw agricultural products (unprocessed or only lightly processed) , life/health insurance , certain medical/veterinary services , and goods/services of business households/individuals with annual revenue under 200 million VND (effective 01/01/2026).
    • Tax Rates (Điều 9):
      • 0%: Applicable mostly to exported goods/services.
      • 5%: Applies to essential goods/services like clean water, fertilizer, medicine, medical equipment, and educational materials.
      • 10%: The standard rate, applying to all remaining goods and services, including digital services provided by foreign suppliers to Vietnamese customers.
  • Effective Date:
    • The main provisions of the Law are effective from July 01, 2025.
    • The new annual revenue threshold (200 million VND) for VAT exemption for business households/individuals takes effect later, from January 01, 2026.

This summary is provided for reference purposes only and highlights key aspects of Law No. 48/2024/QH15. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Law No. 48/2024/QH15 (Official PDF – signed & sealed)

Regulatory Update: Decision No. 3563/QĐ-BTC on New Global Minimum Tax (GMT) Administrative Procedures

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Regulatory Update: Decision No. 3563/QĐ-BTC on New Global Minimum Tax (GMT) Administrative Procedures

Decision No. 3563/QĐ-BTC, issued by the Ministry of Finance on October 21, 2025, announces 04 new administrative procedures within the tax administration field. These procedures are mandatory for Multinational Enterprise (MNE) groups subject to the Global Minimum Tax (GMT) rules, detailing the process for declaration and payment of the top-up tax (QDMTT and IIR) as specified in Decree 236/2025/NĐ-CP.

Key Highlights

  • Scope of Application: The procedures apply to constituent entities of MNE groups, including Joint Ventures and partially-owned entities, responsible for declaring and paying supplementary Corporate Income Tax (CIT).
  • Key Procedures (GMT Updates): The Decision announces four new administrative procedures related to GMT:
    • Notification: Informing the tax authority of the responsible Constituent Entity (CE) and the list of CEs subject to Resolution 107/2023/QH15.
    • Registration/Change: Tax registration/change of registration information for the responsible CE.
    • QDMTT Filing: Filing the supplementary CIT for the Qualified Domestic Minimum Top-up Tax.
    • IIR Filing: Filing the supplementary CIT for the Income Inclusion Rule.
  • Effective Date/Deadline:
    • The Decision is effective from the date of signing (October 21, 2025).
    • The notification deadline is 30 days after the end of the reporting fiscal year.
    • The initial tax registration deadline is 90 days after the end of the reporting fiscal year.
  • Executing Agency: Chi cục Thuế Doanh nghiệp lớn (Large Enterprise Tax Sub-Department)

This summary is provided for reference purposes only and highlights key aspects of Decision No. 3563/QĐ-BTC. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Decision No. 3563/QĐ-BTC (Official PDF – signed & sealed)

Regulatory Update: Decree No. 236/2025/ND-CP on Detailed Regulations for Implementing Global Minimum Tax

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Regulatory Update: Decree No. 236/2025/ND-CP on Detailed Regulations for Implementing Global Minimum Tax

Decree No. 236/2025/NĐ-CP, issued by the Government on August 29, 2025, details the implementation of the Global Minimum Tax (GMT) rules in Vietnam, specifically the Income Inclusion Rule (IIR) and the Qualified Domestic Minimum Top-up Tax (QDMTT). This Decree applies to multinational enterprise (MNE) groups with consolidated revenue exceeding the 750 million EUR threshold and establishes guidelines for determining the tax base, calculating the top-up tax, and specifying filing deadlines.

Key Highlights

  • Scope of Application and Taxpayers: The Decree applies to constituent entities of an MNE group with consolidated revenue of at least 750 million EUR in at least two of the four immediately preceding fiscal years. It outlines detailed rules for calculating the equivalent EUR threshold for non-standard fiscal years and in cases of mergers or demergers.
  • Mechanism of Application (Chapter II):
    • QDMTT (Qualified Domestic Minimum Top-up Tax): Applies to constituent entities operating and residing in Vietnam , ensuring the effective tax rate in Vietnam reaches the 15% minimum.
    • IIR (Income Inclusion Rule): Applies to ultimate parent entities, partially-owned parent entities, and intermediate parent entities in Vietnam that hold direct or indirect ownership in low-taxed foreign constituent entities.
  • Compliance Deadlines (Kê khai, Nộp thuế):
    • Tax Registration: The responsible constituent entity must file the initial tax registration request no later than 90 days after the end of the reporting fiscal year.
    • Filing and Payment: The deadline for filing the Top-up Tax Return (Tờ khai thuế TNDN bổ sung) and paying the tax is 18 months after the end of the fiscal year for the first reporting year, and 15 months for subsequent years.
  • Effective Date: The Decree is effective from October 15, 2025, and is applied starting from the 2024 fiscal year (fiscal years beginning on or after January 1, 2024).

This summary is provided for reference purposes only and highlights key aspects of Decree No. 236/2025/NĐ-CP. For full and legally binding content, please refer strictly to the attached official document.

Attached File:
📎 Decree No. 236/2025/NĐ-CP (Official PDF – signed & sealed)

Regulatory Update: Circular No. 39/2025/TT-BYT on Delegating Authority for Pharmaceutical Tasks and Administrative Procedures

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Regulatory Update: Circular No. 39/2025/TT-BYT on Delegating Authority for Pharmaceutical Tasks and Administrative Procedures

Circular No. 39/2025/TT-BYT, issued by the Ministry of Health (MoH) on September 20, 2025, details the delegation of certain duties and administrative procedures within the pharmaceutical sector, previously under the MoH’s authority, to the Drug Administration of Vietnam (Cục Quản lý Dược) and the Traditional Medicine Administration of Vietnam (Cục Quản lý Y, Dược cổ truyền). This aims to streamline management activities following the issuance of Decree No. 163/2025/NĐ-CP.

Key Highlights

  • Scope of Application: The Circular regulates the delegation of authority for tasks and administrative procedures within the pharmaceutical field belonging to the MoH’s jurisdiction.
  • Delegated Authority (Cục Quản lý Dược – DAV): DAV is assigned to handle procedures for:
    • Licensing the import of most chemical drugs, vaccines, and bio-products, including those not yet registered in Vietnam (e.g., hiếm, điều trị đặc biệt, giá thấp hơn biệt dược gốc).
    • Licensing the import of controlled raw materials (trừ dược liệu độc).
    • Licensing the export of controlled drugs and raw materials.
    • Reviewing price announcements and making recommendations on the wholesale price of prescription chemical drugs, vaccines, and bio-products.
    • Handling licensing procedures for drug manufacturing, import/export, and chain pharmacy businesses.
  • Delegated Authority (Cục Quản lý Y, Dược cổ truyền – TMAV): TMAV is specifically assigned to handle procedures for:
    • Licensing the import/export of traditional medicines and herbal raw materials (dược liệu).
    • Handling licensing procedures for businesses that only produce, import/export, or store traditional medicines, herbal medicines, or raw materials.
    • Reviewing price announcements for traditional prescription medicines.
  • Effective Date: The Circular is effective from September 20, 2025.
This summary is provided for reference purposes only and highlights key aspects of Circular No. 39/2025/TT-BYT. For full and legally binding content, please refer strictly to the official document.
Attached File:

📎 Circular No. 39/2025/TT-BYT (Official PDF – signed & sealed)

 

Regulatory Update: Decree No. 163/2025/ND-CP on Detailed Regulations and Measures for Implementing the Law on Pharmacy

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Regulatory Update: Decree No. 163/2025/ND-CP on Detailed Regulations and Measures for Implementing the Law on Pharmacy

This decree, issued by the Government of Vietnam on June 29, 2025, provides updated regulations on pharmaceutical activities, detailing several articles and offering measures to guide the implementation of the Law on Pharmacy. It includes new provisions on licensing requirements, documentation for import/export, and compliance obligations for pharmaceutical enterprises operating in Vietnam.

Key Highlights

  • Scope of Application: This Decree applies to agencies, organizations, and individuals both domestic and foreign involved in pharmaceutical activities in Vietnam. It details regulations covering activities such as managing the import of unregistered medicines, and rules on the remaining shelf life of imported medicines and raw Materials.

Key Updates related to Import/Export Procedures (Chapter IV):

    • Management of Unregistered Medicines: Specifies criteria and procedures for obtaining import licenses for medicines not yet registered in Vietnam (e.g., for urgent treatment needs, clinical trials, or special treatment needs).
    • Remaining Shelf Life (Hạn Dùng): Details the minimum remaining shelf life for imported medicines and raw materials at the time of customs clearance. For example, a product with a shelf life over 24 months must have a remaining shelf life of at least 18 months, and vaccines must have at least $1/2$ of their shelf life remaining.
    • Specialized Documents: Lists specialized documents required for customs clearance of exported and imported medicines/raw materials.
    • Effective Date: The Decree takes effect from July 01, 2025.

This summary is provided for reference purposes only and highlights key aspects of Decree No. 163/2025/ND-CP. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Decree No. 163/2025/NĐ-CP (Official PDF – signed & sealed)

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Strategic Collaboration Signed to Advance Metabolic Disorder Treatments

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Strategic Collaboration Signed to Advance Metabolic Disorder Treatments

Zealand Pharma A/S and OTR Therapeutics have announced a strategic collaboration and license agreement focused on the discovery and development of novel therapeutics for metabolic diseases. The partnership aims to broaden treatment options for patients with metabolic disorders.

  • Collaboration Focus: The agreement combines Zealand Pharma’s deep expertise in obesity and metabolic health with OTR Therapeutics’ proprietary research platform and capabilities in drug discovery and development. The core focus is on creating next-generation oral small-molecule therapeutics.

  • Responsibilities:

    • OTR Therapeutics: Will be responsible for leading the research and preclinical development phases, utilizing its proprietary discovery platform.

    • Zealand Pharma: Will manage the clinical development, regulatory submissions, and global commercialization of the resulting products.

  • Financial Terms:

    • OTR Therapeutics will receive an upfront payment of $20 million, with the potential to increase to $30 million based on certain conditions.

    • The total potential consideration, largely tied to commercial milestones, could reach up to approximately $2.5 billion through milestone payments associated with preclinical, development, regulatory, and commercial achievements.

    • OTR Therapeutics will also be eligible to receive tiered single-digit royalties on the worldwide net sales of any products that emerge from this collaboration.

A representative from Zealand Pharma noted that the multi-program partnership will expand their metabolic health pipeline into oral small-molecule therapeutics for targets where they possess deep biological expertise, effectively complementing the company’s existing strong peptide R&D platform.

Source: https://www.contractpharma.com/breaking-news/zealand-pharma-otr-therapeutics-sign-deal-to-develop-metabolic-disease-treatments/

China’s NMPA Clears Two Sanofi Treatments for Rare Hematologic Diseases

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China’s NMPA Clears Two Sanofi Treatments for Rare Hematologic Diseases

China’s National Medical Products Administration (NMPA) has granted approvals for two of Sanofi’s rare hematologic disease treatments: Qfitlia (fitusiran) and Cablivi (caplacizumab). These authorizations represent the fourth and fifth clearances for the company in China during 2025.

  • Qfitlia (Fitusiran)

    Qfitlia is an antithrombin-lowering therapy indicated for routine prophylaxis in individuals with hemophilia. It is intended for the prevention or reduction of bleeding episodes in patients aged 12 years and above, as well as in adults with severe hemophilia A or B, regardless of the presence of factor VIII or IX inhibitors.

    The NMPA’s decision is supported by data from the Phase III ATLAS trials, which demonstrated meaningful protection against bleeding across patients, measured by the annualised bleeding rate. Qfitlia functions by lowering antithrombin, a protein that inhibits blood clotting, thereby increasing thrombin generation and helping restore hemostasis in patients. The treatment was also approved by the U.S. Food and Drug Administration (FDA) in March 2025 for routine prophylaxis in patients aged 12 years and older.

  • Cablivi (Caplacizumab)

    Cablivi is a nanobody-targeted therapy approved for acquired or immune-mediated thrombotic thrombocytopenic purpura (aTTP/iTTP) in adults and adolescents aged 12 years or above weighing at least 40 kg.

    The therapy is currently available in 30 countries and regions globally. Cablivi received priority review status for its approval in China and has also been granted priority review by the FDA for a proposed label expansion to include adolescents aged 12 and above.

A Sanofi executive noted that Qfitlia represents a potentially transformative advancement for the hemophilia community in China, shifting care toward prevention rather than just treating bleeds when they occur. Simultaneously, Cabliviaddresses a critical unmet need for patients facing aTTP/iTTP.

Source: https://www.pharmaceutical-technology.com/news/china-sanofi-haematologic-disease/?cf-view

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