Procedures for approving a clinical trial in Vietnam

Procedures for approving a clinical trial in Vietnam (Internet image)

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

1. Procedures for approving a clinical trial in Vietnam

Procedures for approving a clinical trial in Vietnam in Vietnam according to Article 22 of Circular 29/2018/TT-BYT is as follows:

-  The trial facility shall submit an application for approval for clinical trial to the Administration of Science Technology and Training, the Ministry of Health, whether directly or by post.

- The Administration of Science Technology and Training, the Ministry of Health shall verify legality of the application within 05 working days from the receipt of the application. If the application is not satisfactory, the applicant shall be instructed in writing to complete the application until it is satisfactory.

- The applicant shall cooperate with the Administration of Science Technology and Training, the Ministry of Health in completing the application within 60 days from the date on which it is instructed in writing. After the aforementioned deadline, the applicant has to re-apply for approval for clinical trial.

- Within 25 days from the receipt of the satisfactory application, the Ministry of Health shall have a meeting with the National Biomedical Ethics Committee and a record on clinical trial outline assessment shall be made.

- Within 05 working days from the receipt of the record prepared by the National Biomedical Ethics Committee, the Administration of Science Technology and Training shall consolidate and submit a complete application to the Minister of Health for approval. If the clinical trial outline is not approved or needs correcting, the Administration of Science Technology and Training shall respond and provide explanation in writing.

- If the clinical trial outline needs correcting, the applicant shall cooperate with the Administration of Science Technology and Training, the Ministry of Health in completing the application within 90 days from the date on which it is provided with written response and explanation. After the aforementioned deadline, the applicant has to re-apply for approval for clinical trial.

- Within 05 working days from the receipt of the clinical trial outline that is completed as requested, the Administration of Science Technology and Training, the Ministry of Health shall consolidate and submit a complete application to the Minister of Health for approval.

2. Procedures for approving changes to a clinical trial outline in Vietnam

Procedures for approving changes to a clinical trial outline in Vietnam according to Article 23 of Circular 29/2018/TT-BYT is as follows:

- The trial facility shall submit an application for approval for changes to clinical trial outline to the Administration of Science Technology and Training, the Ministry of Health, whether directly or by post.

- The Administration of Science Technology and Training, the Ministry of Health shall verify legality of the application within 05 working days from the receipt of the application. If the application is not satisfactory, the applicant shall be instructed in writing to complete the application until it is satisfactory.

The applicant shall cooperate with the Administration of Science Technology and Training, the Ministry of Health in completing the application within 60 days from the date on which it is instructed in writing. After the aforementioned deadline, the applicant has to re-apply for approval for clinical trial.

- Within 25 days from the receipt of the satisfactory application, the Ministry of Health shall have a meeting with the National Biomedical Ethics Committee and a record on assessment of changes to the clinical trial outline shall be made.

- Within 05 working days from the receipt of the record prepared by the National Biomedical Ethics Committee, the Administration of Science Technology and Training shall consolidate and submit a complete application to the Minister of Health for approval.

If the clinical trial outline is not approved or needs correcting, the Administration of Science Technology and Training shall respond and provide explanation in writing.

- If the clinical trial outline needs correcting, the applicant shall cooperate with the Administration of Science Technology and Training, the Ministry of Health in completing the application within 90 days from the date on which it is provided with written response and explanation. After the aforementioned deadline, the applicant has to re-apply for approval for clinical trial outline.

- Within 05 working days from the receipt of the clinical trial outline that is completed as requested, the Administration of Science Technology and Training, the Ministry of Health shall consolidate and submit a complete application to the Minister of Health for approval.

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE