Vietnam Society of Clinical Research

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Vietnam Stakeholder Glossary

Ministry of Health (MOH – Bộ Y Tế)

  • The MOH is the ultimate regulatory body that grants the final approval to conduct a clinical trial in Vietnam. It does this primarily through its three key departments:
    • Department of Medical Equipment and Infrastructure (DMEC)
    • Drug Administration of Vietnam (DAV)
    • Administration for Science Technology and Training (ASTT)

Department of Medical Equipment and Infrastructure (DMEC – Cục Trang Thiết Bị và Công Trình Y Tế):

  • This is the primary regulatory body for clinical trial oversight. Its roles include:
    • Receiving and formally reviewing the Clinical Trial Application (CTA).
    • Coordinating the scientific assessment of the application via the ASTT.
    • Issuing the final CTA License.
    • Overseeing the conduct of trials, including inspections and handling of major violations.

Drug Administration of Vietnam (DAV – Cục Quản lý Dược):

  • While the DEMHW is the main point of contact, the DAV is involved in trials related to drugs and biologics. Its role includes:
    • Approving the importation of investigational products for the trial.
    • Reviewing the chemical and pharmaceutical documentation of the drug.

Administration for Science Technology and Training (ASTT – Cục Khoa Học Công Nghệ Và đào Tạo)

The ASTT acts as the primary scientific review committee for the MOH. Its role is purely advisory to the MOH.

  • Function: To conduct a detailed scientific and technical review of the CTA.
  • Composition: A panel of independent experts in relevant fields (e.g., oncology, cardiology, statistics, pharmacology).
  • Key Responsibilities:
    • Assess the scientific validity and rationale of the trial.
    • Evaluate the study protocol for its design, methodology, and statistical analysis plan.
    • Review the Investigator’s Brochure (IB) and the qualifications of the investigators.
    • Assess the risk-benefit ratio for study participants.
    • Provide a formal recommendation to the MOH (DEMHW) to either approve, request modifications to, or reject the application.

Ethical Review Bodies (2-Tiered System)

National Ethics Committee in Biomedical Research (NECBR)

  • Role: A central, high-level ethics committee that provides ethical review for specific, high-risk categories of trials.
  • Key Responsibilities:
    • Mandatory Review: It is required to review and approve all clinical trials that fall into the following categories:
      • Trials involving gene therapy, stem cells, or other advanced therapies.
      • Trials with biological products derived from human origin.
      • Phase I and Phase II clinical trials (first-in-human and early-stage studies).
      • Any trial the MOH deems to be of national significance or high ethical sensitivity.
    • Appeals Body: It can act as an appeals board for protocols rejected by a local CEBRGL.
    • Guidance: It issues guidelines and standards for all ethics committees in Vietnam.

Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGL)

  • Role: These are the local Institutional Review Boards (IRBs) established at the hospital or institutional level where the trial is to be conducted.
  • Key Responsibilities:
    • Local Ethical Review: They are responsible for the initial ethical review and approval for trials that do not require mandatory NECBR review (typically many Phase III and IV trials).
    • Local Context: They ensure the trial is appropriate for their local patient population, that the informed consent is culturally and linguistically suitable, and that the site has the resources to protect participants.
    • Continuing Review: They provide ongoing oversight of approved trials within their institution, reviewing amendments, safety reports, and protocol deviations.

How it works: The sponsor and investigator must determine which ethics committee has jurisdiction. A trial for a new chemical entity in Phase I must go to the NECBR. A Phase III trial of a already approved drug for a new indication might only need approval from the local CEBRGL at the participating hospital.

Safety Monitoring & Pharmacovigilance Body

National Centre for Drug Information and Adverse Drug Reaction Monitoring (National DI and ADR Centre)

  • Role: This is Vietnam’s national pharmacovigilance center, operating under the DAV. It is not an approving body but is a critical stakeholder for safety reporting.
  • Key Responsibilities:
    • Receiving Reports: It is the central recipient for all serious adverse event (SAE) reports occurring in clinical trials on Vietnamese territory.
    • Monitoring Safety: It monitors the safety data of investigational products and can issue alerts or recommendations to the MOH/DAV.
    • Post-Approval Safety: Its role continues after a drug is marketed, monitoring adverse drug reactions in the general population.