Clinically trialed objects in healthcare in Vietnam

Clinically trialed objects in healthcare in Vietnam

Pursuant to Article 94 of the Law on Medical Examination and Treatment 2023, clinically trialed objects in healthcare include:

- New healthcare techniques or methods.

- Medical equipment that is ranked highly above-average or high in the risk rating adopted by the Government before being registered for free sale in Vietnam.

Clinically trialed objects in healthcare in Vietnam (Internet image) 

Conditions of participants in clinical trials in healthcare

Pursuant to Article 95 of the Law on Medical Examination and Treatment 2023, conditions of participants in clinical trials in healthcare are stipulated as follows:

(1) Persons who meet the professional requirements of a clinical trial of new technique or method, medical equipment in use in medical examination and treatment activities (hereinafter referred to as clinical trials) and voluntarily participate in clinical trials.

(2) In order to participate in a clinical trial, the participant who is a person who loses his/her capacity to perform civil acts, has impaired cognition or difficulties in behavior control or limited capacity to perform civil acts; the minor patient shall be required to seek the consent from his/her representative or guardian under civil law.

(3) If the participant in a clinical trial is the one specified in clause (2); a pregnant or lactating woman, the research profile shall need to clarify reasons for recruitment and proper actions for protection of the participant, unborn babies or the infants who are being breast-fed by the mother participating in the clinical trial.

Principles and authority of approval of clinical trials in Vietnam

Pursuant to Article 99 of the Law on Medical Examination and Treatment 2023, principles and authority of approval of clinical trials are as follows:

- Clinical trials shall be performed before application of a new technique or method, or marketing authorization of a medical device, except in the case of exemption from clinical trials or exemption from certain phases of a clinical trial.

- A clinical trial shall be conducted only after the profile of that clinical trial has passed the scientific and ethical evaluation by the Ethics Committee on Biomedical Researches referred to in clause 3 of Article 99 of the Law on Medical Examination and Treatment 2023, and after it is approved in writing by the competent authority.

- Ethics Committee on Biomedical Researches is an independent committee set up to protect the rights, safety and health of the participants in clinical trials.

- Conduct of clinical trials, scientific and ethical evaluation of the clinical trial profiles and approval of clinical trials shall adhere to the following basic principles:

= Respect, protect and uphold the self-determination rights of participants in clinical trials;

= Ensure that research interests should prevail over risks incurred during clinical trials;

= Ensure equal benefits and responsibilities; make sure that risks are evenly distributed among clinical trial participants;

= Assure implementation of clinical trial stages and compliance with good practice in testing new techniques, methods or clinical testing of medical devices as instructed by the Minister of Health.

- The Government shall elaborate on the followings:

= Clinical trial stages;

= Cases of eligibility for exemption from clinical trials or certain of clinical trial stages;

= Requirements of new techniques, methods or medical equipment to be clinically trialed;

= Requirements of the testing body;

= Application package, procedures and processes for a clinical trial;

= Establishment of the Ethics Committee on Biomedical Researches.

Mai Thanh Loi

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