Procedures for permitting clinical trial of a new technique/method for medical examination or treatment in Vietnam

Pursuant to the provisions of Article 103 of Decree 96/2023/ND-CP, procedures for permitting clinical trial of a new technique/method include: approving the clinical trial; approving changes to the clinical trial; approving the clinical trial result.

Procedures for approving the clinical trial in Vietnam

- The testing facility shall send 01 application package to the Ministry of Health in person, online or by post;

- The Ministry of Health shall inspect the validity of the application package within 05 working days from the day on which it is received. If the application package is valid, within 02 working days, the Ministry of Health shall transfer it to the National Research Ethics Committee for appraisal of ethical issues. If the application package is invalid, a written notice and instructions to supplement the application package shall be issued within 02 working days.

The testing facility shall complete the application package within 60 days from the receipt of the written notice. After this 60-day period, the procedures for approving the clinical trial must be carried out from the beginning;

- National Research Ethics Committee shall carry out appraisal of ethical issues of the trial on a monthly basis;

- Within 05 working days from the receipt of the certificate of approval for clinical trial from National Research Ethics Committee and enclosed documents, the Ministry of Health shall issue a decision to approve the clinical trial.

Procedures for approving changes to the clinical trial in Vietnam

- The testing facility shall send 01 application package to the Ministry of Health in person, online or by post;

- The Ministry of Health shall inspect the validity of the application package within 05 working days from the day on which it is received. If the application package is invalid, within 02 working days, the Ministry of Health shall issue a written notification and instructions to supplement the application package. The testing facility shall complete the application package within 60 days from the receipt of the written notice. After this 60-day period, the procedures for approving changes to the clinical trial must be carried out from the beginning.

- Regarding the changes mentioned in Point c Clause 3 Article 102 of Decree 96/2023/ND-CP:

= If the application package is valid, within 02 working days, the Ministry of Health shall transfer it to National Research Ethics Committee for appraisal;

= National Research Ethics Committee shall carry out appraisal of ethical issues of the trial on a monthly basis;

= Within 05 working days from the receipt of the certificate of approval for changes to the clinical trial from National Research Ethics Committee and enclosed documents, the Ministry of Health shall issue a decision to approve the changes to the clinical trial.

- Regarding the changes mentioned in Point b Clause 3 Article 102 of Decree 96/2023/ND-CP: Within 07 working days from the receipt of the valid application package, the Ministry of Health shall issue a decision to approve changes to the clinical trial.

Procedures for permitting clinical trial of a new technique/method for medical examination or treatment in Vietnam (Internet image) 

Procedures for approving the clinical trial result in Vietnam

- The testing facility shall send 01 package of application for approval for the clinical trial result to the Ministry of Health in person, online or by post;

- The Ministry of Health shall inspect the validity of the application package within 05 working days from the day on which it is received. If the application package is valid, within 02 working days, the Ministry of Health shall transfer it to the National Research Ethics Committee for appraisal. If the application package is invalid, a written notice and instructions to supplement the application package shall be issued within 02 working days.

The testing facility shall complete the application package within 60 days from the receipt of the written notice. After this 60-day period, the procedures for approving the clinical trial result must be carried out from the beginning;

- National Research Ethics Committee shall evaluate ethical issues of the trial on a monthly basis;

- Within 05 working days from the receipt of the certificate of approval for the clinical trial result from National Research Ethics Committee and enclosed documents, the Ministry of Health shall issue a decision to approve the clinical trial result.

Mai Thanh Loi

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