Bioequivalence (BE) is the evidentiary bridge between a generic and its reference product: same active ingredient is not enough — the generic must reach the body at the same rate and extent. For a facility in Vietnam to run that study, it must satisfy a layered set of conditions spanning clinical practice, laboratory validation and regulatory recognition.
When BE evidence is required
Registration of a generic drug in Vietnam requires BE evidence where the product falls within the scope the registration rules set — typically systemically acting oral dosage forms compared against the reference (innovator or designated comparator) product. Defined exemptions exist for product types where bioavailability is self-evident (such as simple aqueous intravenous solutions). The registration framework was refreshed by Circular 32/2026/TT-BYT (effective 1 October 2026, replacing Circular 12/2025/TT-BYT) under the Pharmacy Law 105/2016/QH13 as amended by Law 44/2024/QH15 — applicants should map their product against the current circular’s BE scope and exemption lists before commissioning any study, because a study designed for yesterday’s scope may answer the wrong question.
Facility conditions: clinic, laboratory, oversight
A Vietnamese BE facility combines two accredited halves. The clinical half must run the study under good clinical practice (GCP): an approved protocol, an ethics committee approval, screened healthy volunteers, controlled dosing and sampling, and medical safety cover. The analytical half must quantify the drug in biological samples with a validated bioanalytical method (typically LC-MS/MS), under laboratory quality systems with documented validation, stability and incurred-sample reanalysis. Above both sits regulatory status: the facility’s eligibility to conduct BE studies must be established under the pharmaceutical framework administered by the Drug Administration of Vietnam — sponsors verify that status for the specific study, not from the facility’s brochure. Foreign-invested sponsors should also settle data ownership and sample export questions (biological samples leaving Vietnam engage additional rules) in the study contract.
Using foreign BE data, and cost realism
Vietnamese registration can accept BE studies performed abroad where the facility and study meet international standards recognised by the registration rules; acceptance remains dossier-specific, and for products of particular sensitivity the authority may still require or weight local data. The safe sequence is a pre-submission consultation on the specific product before commissioning the foreign study. On cost: BE studies are bespoke — molecule, design (single-dose crossover, fasting and fed arms), volunteer count and analytical difficulty drive the price, and no official tariff exists; this article deliberately states no figure. What sponsors can control is comparability of quotes: same protocol synopsis to at least two qualified facilities, with timelines and regulatory-support scope itemised.
Frequently Asked Questions
Must a generic drug undergo BE studies to be marketed?
For generics whose reference product and dosage form fall within the bioequivalence requirements, yes: BE evidence against the reference product is part of the registration dossier. Exemptions exist for defined categories (for example certain simple aqueous solutions), determined by the current registration rules — now Circular 32/2026/TT-BYT on drug registration.
Which facilities may run BE studies in Vietnam?
Facilities that satisfy the conditions for bioequivalence study services: good clinical practice compliance for the clinical phase, a validated bioanalytical laboratory, ethics approval, and recognition/registration with the Drug Administration of Vietnam under the pharmaceutical framework.
Are BE studies by foreign facilities recognised?
Foreign BE data can be accepted where the study was run at a facility meeting international standards (and recognised under the registration rules); acceptance is dossier-specific and the authority may require local data for sensitive products. Plan the recognition question before commissioning the study.
How much does a BE study cost?
There is no state price: cost depends on the molecule, study design (fasting/fed, crossover), volunteer numbers and the analytical method. Sponsors should obtain quotes from qualified facilities rather than rely on any published figure — this article gives no number it cannot verify.
