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

October 10, 2022

New Regulations on Bioequivalence in Vietnam

Subscribe to Updates

On September 5, 2022, the Ministry of Health of Vietnam issued Circular No. 07/2022/TT-BYT on drugs requiring bioequivalence (BE) studies and requirements for dossiers reporting BE data when registering drugs in Vietnam (Circular 07). Circular 07 will take effect on November 1, 2022, replacing Circular No. 08/2010/TT-BYT guiding the reporting of bioavailability/bioequivalence data when registering drugs.

Circular 07 includes provisions on (i) generic drugs containing active pharmaceutical ingredients (APIs) or having dosage forms that require BE reporting when registering the drugs in Vietnam and (ii) dossiers for BE reporting of generic drugs.

The most outstanding point under Circular 07 is that the list of APIs requiring the submission of BE reports in their drug registration dossier includes 26 APIs instead of 12 APIs as specified in the previous circular.

In addition, generic drugs having the following dosage forms must have a BE report in the drug registration dossier:

  • Drugs in immediate-release dosage form, with systemic effects, containing APIs included in the list of 26 APIs and not falling in the cases of BE reporting exemption,
  • Drugs in modified-release dosage form, with systemic effects, that do not fall in the cases of BE reporting exemption.

Roadmap for Application

From November 1, 2022, the registrants of the following drugs must submit a report on BE study data along with the drug registration dossier:

  • Generic enteric-coated drugs, in immediate-release or modified-release form, containing single APIs or fixed-dose API combinations in which the APIs are included in the list of 26 APIs mentioned above.
  • Other generic drugs in modified-release form, except for enteric-coated drugs with APIs excluded from the list of 26 APIs.

From November 1, 2025 (36 months after the effective date of Circular 07), the registrant must submit a BE data dossier along with the drug registration dossier for all generic enteric-coated drugs in modified-release form.

From November 1, 2026 (48 months after the effective date of Circular 07), generic drugs containing APIs or dosage forms requiring BE data that have been granted a Marketing Authorization (MA) previously must be declared as drugs having documents proving bioequivalence.

Transitional Provisions

The MOH has set up a flexible transition mechanism, allowing generic registrants to have the benefits from requesting a MA or obtaining BE studies before November 1, 2022.

For example, the report on BE study data in drug registration/variation/supplementation dossiers submitted before November 1, 2022, may continue to comply with the provisions of Circular No. 08/2010/TT-BYT, unless the MA holders voluntarily comply with Circular 07.

For drugs for which the registration dossiers were submitted before November 1, 2022, no additional reports on BE study data are required before the MA is issued; however, the MA holders must comply with the deadline of 48 months above after the drug is granted a MA.

For BE studies, the solubility equivalence test should be carried out before November 1, 2022, and should have documents proving the origin of the comparator drug or the commitment for the origin of the comparator drugs used in the study.

Related Professionals

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

January 5, 2026
On December 31, 2025, Vietnam’s Ministry of Health (MOH) issued Circular No. 57/2025/TT-BYT providing guidance on the classification of medical devices according to technical standards and quality requirements (Circular 57), applicable to procurement activities for medical devices in Vietnam. According to the MOH, the purpose of the classification is to establish a principle-based legal framework and regulations that enable purchasers to easily identify groups of medical devices aligned with their professional requirements and financial capacity. Some of the key stipulations of Circular 57 are outlined below. Basis for Determining Technical Standards and Quality Under Circular 57, the technical standards of medical devices are determined in accordance with Vietnamese laws on standards and technical regulations, through the following means: Certification of conformity with standards in accordance with Vietnamese laws on standards and technical regulations; Results of conformity assessment conducted by an internationally recognized conformity assessment organization or a legally established domestic or foreign conformity assessment organization operating in Vietnam; and Documentation evidencing compliance provided by the medical device owner. The quality of medical devices is determined based on whether the device has been approved for circulation by the relevant marketing authority of one or more jurisdictions. Classification of Medical Devices Circular 57 classifies medical devices into six groups (from Group 1 to Group 6) based on technical standards and quality. Medical devices subject to classification must simultaneously meet technical standards and quality requirements in accordance with professional specifications and user needs, and must be lawfully marketed in Vietnam. Medical devices manufactured in Vietnam may participate in all corresponding groups, provided they meet the technical standards required by the user and are lawfully marketed in Vietnam. Outlook Circular No. 57 will take effect on February 15, 2026, while the classification requirements will become effective on January 1, 2027. Holders of medical
Read More
November 25, 2025
Food safety incidents can emerge without warning, requiring businesses to act swiftly to protect consumers and comply with regulatory obligations. Across Southeast Asia, Thailand, Vietnam, and Indonesia have each developed comprehensive food recall frameworks designed to ensure rapid removal of unsafe products from the market while holding businesses accountable for compliance failures. While these three jurisdictions share common objectives—protecting public health and ensuring food safety—each has crafted distinct regulatory approaches reflecting their unique administrative structures, enforcement priorities, and legal traditions. Understanding these differences is essential for food businesses operating in the region, as recall procedures, timelines, reporting requirements, and penalties vary significantly across borders. This guide, available through the button below, examines the food recall regulations in Indonesia, Thailand, and Vietnam, providing practical guidance on legal requirements, procedural steps, and compliance obligations in each market.
Read More
November 18, 2025
On November 13, 2025, Thailand’s Alcoholic Beverage Control Committee (ABCC) approved a draft announcement to lift the ban on the afternoon sale of alcohol for 180 days from the announcement’s effective date, which is expected to be in early December. Development of the draft was first set in motion when the cabinet approved economic stimulus measures on October 21, 2025. Subsequently, the Ministry of Public Health’s Department of Disease Control proposed revisions to alcohol sales hours to reduce operational constraints for tourism-facing businesses. The policy intent is to align rules for restaurant and café premises and retail operations with tourism demand while maintaining key public health guardrails. Change in Alcohol Sales Hours After the announcement takes effect, alcohol sales hours in Thailand will be changed in accordance with the table below, for a period of 180 days. What Remains Unchanged Midnight alcohol sales cutoff Advertising and marketing restrictions Seller duties (ID checks, intoxication assessment, licensing) Possibility of Extension The contemplated 180-day relaxation is targeted, time bound, and tailored to tourism recovery. It simplifies operational planning by eliminating the midday gap, enabling continuous service for lunch and late-afternoon sales across restaurants, cafés, bars, and other establishments. Data on the impact of the relaxation on tourism spending, public health indicators, and public order will be collected and sent to the ABCC for consideration of a possible extension beyond 180 days.
Read More