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​ 

October 25, 2023
Cambodia’s Ministry of Health (MOH) continues to increase awareness among the public and private sector of the need for strict healthcare regulations and strict enforcement to advance the quality of the country’s healthcare sector. In April 2023, the MOH issued a notification letter reminding advertisers of health products that they need to obtain a permit before advertising their products in Cambodia. On October 12, 2023, the MOH issued two press releases on continued noncompliance in the healthcare sector. The two press releases address the illegal advertising of both healthcare products and private healthcare services. The releases also address unlicensed healthcare professionals and general noncompliance by private healthcare services. These releases indicate that the MOH, in cooperation with local authorities, will substantially increase its enforcement efforts across Cambodia. Since October 12, several private healthcare clinics have had their operations closed and licenses suspended or revoked, signaling the ministry’s intent to enforce the legal framework. Noncompliant Advertising of Health Products The first press release focuses on the continued illegal advertising of health products and the advertising of unregistered health products. Health products include modern medicines, traditional medicines, health supplements, medical devices, cosmetics, and other products that prevent or treat diseases. The release highlights that the MOH has noticed ongoing unauthorized and illegal advertising, commenting that these are often found online and on social media. The noncompliant advertising referenced in the release includes advertising of health products without the required advertising permit, advertising products that are not properly registered with the MOH, and advertising by unlicensed companies and individuals. The MOH also states in the release that some advertisements are using inappropriate and noncompliant content that is not based on medical science and exaggerates the qualities of the health products—specifically mentioning skin-whitening cosmetics. The ministry’s press release also informs the public of
Read More
October 25, 2023
One significant development in the health sector in Indonesia is the use of information technology and communication in the implementation of health efforts—particularly digital health services such as telehealth and telemedicine integrated into the country’s National Health Information System. This development was addressed in a major new piece of legislation for the healthcare sector in Indonesia. Enacted in August 2023, Law No. 17 of 2023 concerning Health (the “Health Law”) provides the updates needed to support the development of healthcare services in Indonesia. Under the Health Law, health information system (HIS) providers must: Carry out processing of data and health information in the territory of Indonesia, except for certain limited and specific processing activities that may be conducted outside Indonesia when permitted by the relevant authorities and in compliance with relevant regulations. Ensure the reliability of its HIS, including availability, security, maintenance, and integration with Indonesia’s National Health Information System. Provide quality health data and information. Process data and health information, which includes planning, collection, storage, inspection, transfer, utilization, and destruction. Record its data- and information-processing history. Protect every person’s data and health information. Obtain approval from the relevant personal data subject or comply with relevant regulations if the processing of data and health information involves an individual’s health data. Inform the data owner if there is a failure to protect data and individual health information. The Health Law’s personal data protection requirements listed above appear to be aligned with the provisions in Law No. 27 of 2022 concerning Personal Data Protection (the “PDP Law”). Under this law, data and information relating to health are identified as “specific personal data,” the processing of which carries a high potential risk of impacting the relevant personal data subject. In the implementation of digital health services, patients’ personal data or medical records
Read More
October 19, 2023
Cambodia’s Law on Food Safety came into force on June 8, 2022. This law has been widely regarded as a major legal development of the food safety framework in Cambodia, providing new rules, clarifying existing rules, and setting a clear framework for its implementation and enforcement. In addressing some of the key features of this new law shortly after it was passed in 2022, we remarked that we eagerly await implementing regulations. Since then, various regulations have been adopted, such as two regulations (Sub-Decree No. 13 and Prakas No. 80) on food surveillance, recalls, and seizure. These implementing rules are essential in ensuring that enforcement officers can remove noncompliant and unsafe foods from the market. Another key aspect of the Law on Food Safety is that it requires Khmer-language labeling on prepackaged food products. There has been a notable increase in the inclusion of Khmer labeling on food products in the market since June 2022, but noncompliance is still considerable, especially for imported foods. Further interesting labeling rules set by the Law on Food Safety include a requirement to provide nutrition information. This requirement has not yet been widely adopted, with many in the industry highlighting that the details of this labeling requirement are not clear. Indeed, the relevant article of the Law on Food Safety itself only sets the requirement for food products to bear nutrition labeling and does not spell out what detailed information should be provided or in what manner. However, a prakas (ministerial regulation) adopted months prior to the Law on Food Safety does set out clear guidance on nutrition labeling. As long as this earlier regulation is not replaced or abrogated, and as far as it does not conflict with later laws or regulations, it can be relied upon for guidance. What are the
Read More
September 20, 2023
Thailand is preparing to open its first renewal period for drug marketing authorizations (MAs) since the passage of the Drug Act (No. 6) B.E. 2562 (2019). Before 2019, MAs for pharmaceuticals and vaccines in Thailand had lifelong validity. The 2019 Drug Act stipulated that all new MAs would be valid for seven years and could be renewed. The 2019 law also set out expiration dates for existing pharmaceutical products registered and approved prior to the implementation of the law (i.e., before October 13, 2019): Drug MAs issued before January 1, 1997, expire on October 13, 2024. Drug MAs approved between January 1, 1997, and December 31, 2007, expire on October 13, 2026. Drug MAs approved between January 1, 2008, and October 13, 2019, expire on October 13, 2028. Based on these dates, the first renewal period for drug MAs will commence in the fourth quarter of 2023. To facilitate the renewal process, the Thai Food and Drug Administration (FDA) has publicized draft regulations and notifications on the required application form and documents, the rules and conditions, and the process for renewing an MA. In May 2023, the Thai FDA issued Ministerial Regulation Re: Renewal of Drug MA Licenses B.E. 2566 (2023) to prescribe the essential requirements for filing a renewal application: To renew a drug MA, holders must submit their renewal application to the Thai FDA within the one-year period before the MA’s expiration date. Renewal applications can only be submitted online via the Thai FDA’s electronic system. The Thai FDA will grant approval for an MA renewal if the following conditions are satisfied: The documents in relation to efficacy and safety are up-to-date, accurate, and in accordance with academic principles. The specification and analytical method comply with the official pharmacopeias as prescribed in the Drug Act, as amended.
Read More