You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

July 15, 2025

Vietnam Updates Guidelines on Drug Quality Standards, Testing, and Noncompliance

Subscribe to Updates

On July 1, 2025, Vietnam’s Ministry of Health issued Circular No. 30/2025/TT-BYT providing updated guidance on the application of drug quality standards, testing of drugs and pharmaceutical ingredients, and procedures for the recall and handling of noncompliant drugs (Circular 30). Circular 30 officially came into effect on the same day and replaces Circular No. 11/2018/TT-BYT and its amendments.

Key highlights of Circular 30 are presented below.

Drug and Pharmaceutical Ingredient Quality Standards

Circular 30 maintains consistency with previous regulations regarding the selection of an applicable quality specification. Pharmaceutical businesses and drug preparation establishments may still choose to apply standards from the Vietnamese Pharmacopoeia, reference pharmacopoeias (including the United States Pharmacopoeia, the European Pharmacopoeia, the British Pharmacopoeia, the Japanese Pharmacopoeia, and the International Pharmacopoeia), or an in-house specification.

Priority is given to the Vietnamese Pharmacopoeia and reference pharmacopoeias, encompassing quality indicators, quality levels, and testing methods. If alternative pharmacopoeias or in-house specifications are used, they must meet the requirements outlined in the corresponding monographs of the Vietnamese or reference pharmacopoeias.

At the time of registration, the quality standards of drugs and pharmaceutical ingredients must comply with either the current version of the pharmacopoeia or a previous version of the pharmacopoeia that is no more than two years older than the current version.

The requirement for updating quality specifications in line with the quality under the corresponding pharmacopoeia also applies to products that have already been granted marketing authorization.

Testing Drugs and Pharmaceutical Ingredients in Quality Management

Similar to the regulations under the previous circular, if pharmaceutical businesses disagree with the sample testing results, they may, within five working days of receiving the test report, request that the state quality inspection authority designate an alternative testing facility.

The testing period for establishments listed as foreign drug manufacturers with quality violations remains largely unchanged. However, Circular 30 reduces the mandatory testing duration from 12 months to 6 months for manufacturers with two batches classified as having Level 3 quality violations.

Newly added under Circular 30, vaccines and biological products such as antibody-containing sera and blood/plasma derivatives must undergo testing before being released to the market. In addition to the National Institute for Control of Vaccines and Biologicals, businesses may submit samples to other designated testing facilities listed by the Drug Administration of Vietnam (DAV).

Circular 30 introduces provisions for exemption from one or more pre-market testing procedures for vaccines and biologicals (excluding first-time imports). For example, non-injectable vaccines and biologicals imported from countries with stringent regulatory authorities (SRAs) may be exempt from pre-market testing procedures, while injectable vaccines and biologicals imported from SRA-member countries may be exempt from testing one or multiple quality indicators.

Recall and Handling of Noncompliant Drugs

Circular 30 clearly defines the roles and responsibilities of the provincial and municipal health departments in receiving information and handling noncompliant drugs in the area.

The voluntary drug recall process has also been revised. Specifically, after detecting a drug that violates or shows signs of violating quality standards, and assessing and determining the severity of the violation, pharmaceutical businesses are now permitted to initiate a recall without prior approval from the DAV. They may proceed to recall the affected drug, notify the distribution and usage establishments that received it, and conduct the recall. These actions can be carried out in parallel with submitting a report on noncompliance to the DAV that includes information related to the violations, the self-assessed violation level, and the scope of the recall. This represents a significant shift from the previous procedure, which required businesses to wait for official approval before initiating a recall.

Outlook

Circular 30 is expected to have a significant impact on pharmaceutical businesses and drug preparation establishments. These entities should carefully review the document to facilitate their activities and to ensure compliance with Vietnamese regulations.

Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

May 11, 2026
Vietnam’s legal framework governing chemicals has undergone significant reform, with the Law on Chemicals No. 69/2025/QH15 (Law on Chemicals 2025) taking effect on January 1, 2026. Together with a comprehensive set of implementing instruments issued in January 2026, including three decrees (No. 24/2026/ND‑CP, No. 25/2026/ND‑CP, and No. 26/2026/ND‑CP) and two circulars (No. 01/2026/TT‑BCT and No. 02/2026/TT‑BCT), the Law on Chemicals 2025 has significantly reshaped chemical registration and management requirements. Determining What Constitutes a “New Chemical” Among the most notable changes introduced under the Law on Chemicals 2025 are the rules governing the registration and management of new chemicals, which must be registered with the authority before being placed on the Vietnam market. Although the concept of new chemical registration was first introduced under the Law on Chemicals 2007, the corresponding registration mechanism has remained largely dormant in practice. Under the Law on Chemicals 2025, a “new chemical” is defined as a substance that is not yet included in Vietnam’s National Chemical Inventory and the list of foreign chemical inventories recognized by the competent Vietnamese authority (List of Foreign Chemicals). On a literal reading, the definition in the new law may suggest that a substance qualifies as a new chemical only if it is absent from both lists. Accordingly, a chemical present in either list should be treated as an existing chemical without the registration burden. However, a different interpretation emerges from Decree 26, which specifically requires registration of “new chemicals” even where such substances already appear in the List of Foreign Chemicals. This implies that inclusion in a recognized foreign inventory does not automatically exempt a substance from new chemical registration in Vietnam. This inconsistency between the statutory definition in the Law on Chemicals 2025 and the implementing provisions of Decree 26 creates significant interpretative and compliance challenges. At
Read More
April 29, 2026
Effective June 22, 2026, Thai Industrial Standards (TIS) for food contact paper and cooking paper will be enforced as mandatory for sale in the Thai market. This move has important implications for product licensing and tightens hygiene, labeling, and chemical-safety requirements for food-contact and cooking paper products. Thailand is strengthening its regulatory framework for paper-based culinary materials against a backdrop of accelerating global commitments to ESG and sustainability, as such materials—particularly those derived from natural or recycled fibers—have emerged as key alternatives to plastics in food preparation, cooking, and packaging applications. As a result, regulators worldwide are tightening controls to ensure that sustainability initiatives do not compromise consumer safety, particularly regarding the potential migration of chemical substances into food. Regulatory Framework: Voluntary vs. Mandatory Standards Standards under the TIS regime are generally classified into two categories. Voluntary standards allow manufacturers or importers to apply for a product license and affix the TIS mark to demonstrate product quality and build consumer confidence, but compliance is not legally required. Mandatory standards, by contrast, require manufacturers and importers to obtain a product license and affix the TIS mark before placing products on the Thai market, and noncompliant products cannot be legally sold. Previously, the TIS standards for food contact paper (TIS 2948-2562) and cooking paper (TIS 3438-2022) fell under the voluntary standard regime, meaning that obtaining a TIS license and displaying the TIS mark was optional. However, due to the increasing use of paper in food preparation and cooking, the Thai Industrial Standards Institute has determined that upgrading these standards to mandatory status is necessary to enhance consumer safety. As a result, all paper intended for food contact or cooking purposes must now obtain a TIS product license prior to sale in Thailand. Scope of the Standards The primary distinction between the
Read More
April 22, 2026
A new decree in Vietnam brings significant implementation clarity to the country’s existing extended producer responsibility (EPR) legal framework. An EPR mechanism was first codified in Vietnam in the 2020 Law on Environmental Protection amid ongoing challenges surrounding the collection and treatment of product and packaging waste. The mechanism was progressively detailed through Decree No. 08/2022/ND‑CP and its successive amendments, but the regulatory framework remained insufficiently developed, notably in terms of support mechanisms for waste collection, recycling, and treatment. The newly launched regulations in Decree No. 110/2026/ND-CP (Decree 110), issued on April 1, 2026, and taking effect on May 25, 2026, stipulate fully and clearly the responsibility of manufacturers and importers to recycle products and packaging and to treat waste. Some key provisions of Decree 110 for manufacturers, importers, and related stakeholders are presented below. Subjects of EPR The Law on Environmental Protection assigns responsibility to manufacturers and importers for product and packaging recycling (under Article 54) or waste collection and treatment (under Article 55), depending on the type of products and packaging they produce or import. Decree 110 elaborates on these EPR provisions by specifying the responsible entities and listing out the types of products and packaging subject to recycling and waste treatment responsibilities. Decree 110 clarifies the responsible entities in special cases, such as when products under the same brand are made by multiple manufacturers, when there is a contract manufacturing or entrusted import relationship, and when the manufacturer or importer is part of a corporate group. Notably, exemptions may be applied in some scenarios, such as for manufacturers and importers of products and packaging exclusively for export, temporary import and re-export, or research and testing purposes, as well as for entities with annual revenue from related products not exceeding VND 30 billion. Recycling Responsibilities Decree 110
Read More
March 30, 2026
In response to an emerging crisis on food safety, the government of Vietnam promulgated Decree No. 46/2026/ND-CP (Decree 46) on January 26, 2026, and Resolution No. 66.13/2026/NQ-CP (Resolution 66.13) on January 27, 2026, setting out a number of substantive changes to the procedure and strict requirements for the declaration, registration, and importation of food products. Both instruments took effect upon issuance. However, shortly after they entered into force, food businesses encountered significant implementation challenges, particularly with respect to state inspection procedures at the customs clearance stage for imported products. In response, the government issued Resolution No. 09/2026/NQ-CP (Resolution 09) on February 4, 2026, temporarily suspending Decree 46 and Resolution 66.13 until a new effective date of April 16, 2026. Continued Suspension of Implementation of Decree 46 and Resolution 66.13 After considering feedback gathered by the Ministry of Health from food businesses and other stakeholders during the suspension period, the Vietnam Government Office issued a notice on March 20, 2026, agreeing to extend the suspension until the issuance of an amended Law on Food Safety and its guiding decree. Following this notice, on March 22, 2026, the Ministry of Health prepared a draft resolution to implement the notice and replace Resolution 09. Under the draft resolution, the effectiveness of Decree 46 and Resolution No. 66.13 would continue to be suspended until the amended Law on Food Safety takes effect, except for the provisions under Resolution 66.13 allowing flexibility in documents evidencing product efficacy, which would take effect on April 16, 2026, and remain effective until the Law on Food Safety is replaced (but not later than February 28, 2027). Accordingly, for products subject to the registration declaration procedure, such as health supplements, efficacy may be substantiated by either (i) scientific evidence supporting the declared function and effects of the product
Read More