Circular 44/2026/TT-BYT amend Circular 07/2022/TT-BYT on drugs subject to in vivo bioequivalence trial and dossier requirements

CIRCULAR

Amending and supplementing a number of articles of the Minister of Health’s Circular No. 07/2022/TT-BYT providing 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

Pursuant to the Law on Pharmacy No. 105/2016/QH13, amended and supplemented under Law No. 44/2024/QH15;

Pursuant to the Government’s Decree No. 163/2025/ND-CP detailing a number of articles, and prescribing measures for organizing and guiding the implementation, of the Law on Pharmacy;

Pursuant to the Government’s Decree No. 313/2026/ND-CP defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration of Vietnam;

The Minister of Health hereby promulgates the Circular amending and supplementing a number of articles of the Minister of Health’s Circular No. 07/2022/TT-BYT providing 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.

Article 1. To amend Clause 3, Article 14

“3. From November 01, 2028, generic drugs containing pharmaceutical ingredients or formulation subject to in vivo bioequivalence trial under this Circular, which have been granted certificates of free sale shall:

a) Continue to be manufactured, imported and put into circulation only when they are declared as having documents proving bioequivalence; except for domestically manufactured drug batches and imported drug batches already delivered at the exporting country's post of departure before November 01, 2028, which shall continue to be circulated until their expiry date;

b) Have their certificates of free sale extended only when they already have documents proving bioequivalence that meet requirements. For drugs for which the application dossiers for extension of  certificates of free sale, and application dossiers for classification of drugs with proven bioequivalence have been submitted under Point c of this Clause, the processing of  application dossiers for extension of  certificates of free sale shall be carried out concurrently with the processing of application dossiers for classification of drugs with proven bioequivalence;

c) The declaration of drugs with documents proving bioequivalence according to the roadmap specified in this Clause shall 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.”.

Article 2. To amend and supplement Article 17

1. To add Point d after Point c, Clause 1 as follows:

“d) Organize the declaration and updating of the List of undeclared drugs with documents proving bioequivalence on the Drug Administration of Vietnam's website from July 01, 2027.”.

2. To add Clause 1a after Clause 1 as follows:

“1a. 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.”.

Article 3. Effect

This Circular takes effect from November 01, 2026.

Any difficulties arising in the course of implementation should be reported to the Ministry of Health (the Drug Administration of Vietnam) for consideration and settlement./.