New Regulations on Bioequivalence in Vietnam

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.

By Tilleke & Gibbins, Vietnam, a Transatlantic Law International Affiliated Firm. 

For further information or for any assistance please contact vietnam@transatlanticlaw.com

Disclaimer: Transatlantic Law International Limited is a UK registered limited liability company providing international business and legal solutions through its own resources and the expertise of over 105 affiliated independent law firms in over 95 countries worldwide. This article is for background information only and provided in the context of the applicable law when published and does not constitute legal advice and cannot be relied on as such for any matter. Legal advice may be provided subject to the retention of Transatlantic Law International Limited’s services and its governing terms and conditions of service. Transatlantic Law International Limited, based at 42 Brook Street, London W1K 5DB, United Kingdom, is registered with Companies House, Reg Nr. 361484, with its registered address at 83 Cambridge Street, London SW1V 4PS, United Kingdom.