Phases of clinical trial under the law in Vietnam

Phases of clinical trial under the law in Vietnam (Internet image)

Regarding this matter, LawNet would like to answer as follows:

1. Phases of clinical trial under the law in Vietnam

The phases of clinical trial in Vietnam according to Article 86 of the Law on Pharmacy 2016 are as follows:

- Phase 1 is the first phase of testing in humans to make a preliminary assessment of drug safety.

- Phase 2 is meant to determine the optimal dose for clinical trial and prove the safety and efficacy of the drug, including the ability of the vaccine to stimulate development of immunity in users.

- Phase 3 is carried out on large scale to determine the stability of the formula, the overall safety and efficacy of the drug, or to assess the protective effect and safety of vaccine in users.

- Phase 4 is carried out after the drug is permitted for free sale in order to keep assessing its safety and efficacy or monitor the protective effect of the vaccine after it is widely used under prescribed conditions.

2. Requirements applied to drugs undergoing clinical trial in Vietnam

Requirements applied to drugs undergoing clinical trial in Vietnam according to Article 88 of the Law on Pharmacy 2016 are as follows:

- A drug undergoing clinical trial must satisfy the following conditions:

+ It has undergone pre-clinical trial;

+ It has a stable dosage form;

+ It meets quality standards according to the application for clinical trial.

- On the label of the drug used for clinical trial must have the text “Thuốc dùng cho thử lâm sàng. Cấm dùng cho Mục đích khác” (“For clinical trial only”).

3. Conditions for a person to participate in clinical trial in Vietnam

Conditions for a person to participate in clinical trial in Vietnam according to Article 90 of the Law on Pharmacy 2016 are as follows:

- The clinical trial subject must be a volunteer who satisfy clinical trial requirements, signs an agreement on voluntary participation in the clinical trial with the provider of clinical trial services, except for people who have limited legal capacity or have no legal capacity.

- If a clinical trial subject is a minor, has limited legal capacity or has no legal capacity, it is required to have his/her guardian’s consent as prescribed by law.

- If a clinical trial subject is a pregnant woman, the trial documents must specify the reasons and measures shall be taken to protect her.

4. Principles and the power to approve clinical trial services in Vietnam

Principles and the power to approve clinical trial services in Vietnam according to Article 94 of the Law on Pharmacy 2016 are as follows:

-  A clinical trial may only be carried out after a National Biomedical Ethics Committee assesses its scientificity and ethical aspects according to clinical trial documents and the Minister of Health grants an approval in writing.

- The clinical trial, the assessment of its scientificity and ethical aspects and the grant of approval for a clinical trial shall comply with the following principles:

+ Respect the right of decision of clinical trial subjects; protect people whose right of decision is limited;

+ Ensure that the trial offers more benefits than risks; the risks are carefully considered and minimized according to standards;

+ Ensure that rights and obligations of clinical trial subjects are equal; benefits and risks are equally shared among the clinical trial subjects;

+ Ensure the completion of clinical trial phases and fulfillment of Good Clinical Practice requirements.

- Biomedical Ethics Committees are independent national and internal committees established to protect the rights, safety, and health of clinical trial subjects.

The Minister of Health shall provide for the establishment, functions, tasks, and entitlements of Biomedical Ethics Committees.

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