The Ministry of Health has issued Circular No. 44/2026/TT-BYT, which amends and supplements regulations on drugs requiring in vivo bioequivalence trials in Vietnam. The new rules govern how generic drugs are manufactured, imported, and circulated, aiming to improve the quality and safety of medicines in the market. Signed by Do Xuan Tuyen on November 1, 2026, this document amends a number of articles of the Minister of Health’s Circular No. 07/2022/TT-BYT, which provides for regulations on drugs subject to in vivo bioequivalence trial and requirements for dossiers on bioequivalence trial data reporting upon registration for circulation of drugs in Vietnam.
Changes to the Bioequivalence Rules
The circular modifies Article 14 of Circular No. 07/2022/TT-BYT. From November 1, 2028, generic drugs containing pharmaceutical ingredients or formulation subject to in vivo bioequivalence trial may be manufactured, imported and put into circulation only when they are declared as having documents proving bioequivalence; This requirement is established pursuant to the Law on Pharmacy No. 105/2016/QH13, amended and supplemented under Law No. 44/2024/QH15, and the Government’s Decree No. 163/2025/ND-CP detailing measures for organizing and guiding the implementation of the Law on Pharmacy.
There is a transitional period for batches already in transit. Domestic batches produced and imported drug batches delivered at the exporting country’s post of departure before November 1, 2028, may continue to be sold until their expiry date. For these existing stocks, the extension of certificates of free sale is permitted only if the owner has documents proving bioequivalence that meet the requirements. This transitional measure applies specifically to domestically manufactured drug batches and imported drug batches already delivered at the exporting country’s post of departure before November 01, 2028.
For applications submitted after the deadline, the processing of extensions for certificates of free sale will be handled concurrently with the classification of drugs as having proven bioequivalence. The circular takes effect on November 1, 2026, and applies to organizations and individuals involved in the production, importation, and circulation of drugs in Vietnam, particularly generic drugs subject to in vivo bioequivalence trial.
From July 1, 2027, the Drug Administration of Vietnam will publish and update a list of drugs that do not have documents proving bioequivalence on its official website. Organizations and individuals holding drugs that are undergoing bioequivalence trials must also disclose this list on their own websites.
Publication and Website Disclosure
Organizations and individuals owning drugs put for bioequivalence trial shall take responsibility in accordance with Clause 2, Article 98 of the Law on Pharmacy and publicize the List of declared or undeclared drugs with documents proving bioequivalence on their websites according to the roadmap specified in this Circular.
Implementation and Reporting
The declaration of drugs with documents proving bioequivalence must comply with Articles 47 and 55 of the Minister of Health’s Circular No. 32/2026/TT-BYT on circulation registration of drugs and drug materials.
