Clinical trials in Vietnam: conditions for foreign sponsors

Vietnam is becoming an attractive clinical trial destination thanks to its large population, competitive costs and experienced central hospitals. For a foreign sponsor, however, a clinical trial is not an ordinary outsourced service: it is a conditional activity that needs Ministry of Health approval, ethics committee clearance, and participant protections that the sponsor cannot contract out of.

Baseline conditions for the sponsor and the trial site

A drug may only enter clinical trials in Vietnam where permitted under Law on Pharmacy 105/2016/QH13, as amended by Law 44/2024/QH15 effective from 1 July 2025, and the study may only run at a healthcare facility meeting good clinical practice conditions for drug trials. A foreign sponsor usually does not operate the study at site level directly; it works through an eligible hospital as the trial institution, with a principal investigator professionally responsible on site.

On the legal entity side, the sponsor needs a lawful presence or an authorised organisation in Vietnam to contract, import the investigational product and stand behind compensation obligations. Trial drugs are imported under a dedicated research mechanism, may not be used commercially, and the whole process must follow good clinical practice principles including serious adverse event reporting duties.

Two-tier approval: ethics and technical review

A clinical trial protocol in Vietnam passes two independent layers of review. The first is the ethics committee in biomedical research, which examines the balance of benefits and risks, the informed consent documents and protections for vulnerable groups. The second is Ministry of Health approval of the protocol, the investigational product and the trial institution. Recruitment of participants may only begin once both approvals are in place.

During the study, material protocol amendments, added sites or a change of principal investigator also need supplementary approval before implementation, except for urgent measures removing an immediate hazard to participants. Sponsors used to a single central approval abroad should budget time for both layers when planning global recruitment timelines.

Participant rights and data ownership

Participants have the right to full information before signing consent, the right to withdraw at any time without affecting their routine care, and the right to treatment and compensation where trial-related injury occurs. Responsibility for securing these rights rests with both the sponsor and the trial institution, and funding for the compensation mechanism must be built into the study budget from the outset.

Trial data is handled under the agreement between the sponsor and the trial institution, where the usual pattern is that the sponsor owns the study dataset used for drug registration, while the institution keeps access to its own site data for academic purposes as agreed. All processing of participants’ personal data must comply with Law on Personal Data Protection 91/2025/QH15 and Decree 356/2025/ND-CP, which replaced Decree 13/2023/ND-CP from 1 January 2026, especially where data moves abroad to the sponsor.

Frequently Asked Questions

What conditions must a foreign sponsor meet for a clinical trial in Vietnam?

A foreign sponsor must ensure: the drug is eligible for clinical trial under Law on Pharmacy 105/2016/QH13 as amended by Law 44/2024/QH15; the study sits at a healthcare facility meeting good clinical practice conditions for drug trials; there is a lawful presence or an authorised organisation in Vietnam to contract and bear responsibility; and the study budget pre-funds a compensation mechanism for participants injured in connection with the trial.

How does trial approval work?

Approval has two tiers: the ethics committee in biomedical research appraises the protocol for benefits, risks and consent documents, and the Ministry of Health then approves the technical side, the investigational product and the trial institution. Participant recruitment may start only when both approvals exist. Material protocol changes during the study likewise need supplementary approval before they are applied.

What rights do trial participants have?

Participants are entitled to complete information and voluntary written consent, to withdraw at any time without affecting routine treatment, and to treatment and compensation where injury is caused by the trial. Vulnerable groups receive extra protection in ethics review, and payments to participants may only reasonably offset their burden rather than act as an inducement to join.

Who owns the trial data?

Data ownership is set by the contract between sponsor and trial institution, with the common pattern that the sponsor owns the study dataset supporting global drug registration filings, while the institution may use its own site data for scientific purposes as agreed. Whatever the contract says, processing and transferring participants’ personal data abroad must still comply with Law 91/2025/QH15 and Decree 356/2025/ND-CP.

Bottom line for sponsors

Clinical trials in Vietnam are feasible and increasingly encouraged, but a foreign sponsor must clear both ethics and technical approval tiers, choose an eligible trial institution, and lock compensation and data rights into the contract from the start. Get those three right and the later phases of the study run smoothly.