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

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

1. Requirements for the facility carrying out clinical trial of the new technique/method in Vietnam

According to Article 101 of Decree 96/2023/ND-CP, the requirements for the facility carrying out clinical trial of the new technique/method in Vietnam include:

- Complying with good clinical practice guidelines for new techniques and methods as stipulated by the Minister of Health.

- The facility conducting clinical trials must be a medical examination and treatment facility with the appropriate scope of professional activities relevant to the new techniques and methods undergoing clinical trials.

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

According to Article 103 of Decree 96/2023/ND-CP, the procedures for permitting clinical trial of a new technique/method for medical examination or treatment in Vietnam are as follows:

- The process and procedure for granting clinical trial approval include: approval of the clinical trial; approval of clinical trial changes; approval of clinical trial results.

- Process and procedure for clinical trial approval:

+ The facility conducting the clinical trial submits directly, online, or by mail one application dossier requesting clinical trial approval to the Ministry of Health of Vietnam;

+ The Ministry of Health of Vietnam reviews the validity of the dossier within 05 working days from the date of receipt. If the dossier is valid, within 02 working days, the Ministry of Health of Vietnam forwards the dossier to the National Ethics Committee for research ethics review and assessment. If the dossier is invalid, within 02 working days, the Ministry of Health of Vietnam must issue a notification with specific instructions for the facility to supplement the dossier.

The facility conducting the clinical trial is responsible for completing the dossier within a maximum of 60 days from the date of receiving the notification. Beyond this period, the clinical trial approval procedure must be restarted;

+ The National Ethics Committee conducts monthly periodic reviews and assessments of research ethics;

+ Within 05 working days from the date of receiving the clinical trial approval certificate from the National Ethics Committee and the accompanying dossier, the Ministry of Health of Vietnam grants the clinical trial approval.

- Process and procedure for approval of clinical trial changes:

+ The facility conducting the clinical trial submits directly, online, or by mail one application dossier requesting approval for clinical trial changes to the Ministry of Health of Vietnam.

+ The Ministry of Health of Vietnam reviews the validity of the dossier within 05 working days from the date of receipt. If the dossier is invalid, within 02 working days, the Ministry of Health of Vietnam must issue a notification with specific instructions for the facility to supplement the dossier until it is valid. The facility conducting the clinical trial is responsible for completing the dossier within a maximum of 60 days from the date of receiving the notification. Beyond this period, the clinical trial change approval procedure must be restarted.

+ For changes specified in point c, clause 3, Article 102 of Decree 96/2023/ND-CP:

++  If  the  dossier  is  valid,  within  02  working  days,  the  Ministry  of  Health  forwards  the  dossier  to  the  National  Ethics  Committee  for  review;

++  The  National  Ethics  Committee  conducts  monthly  periodic  reviews  and  assessments  of  research  ethics;

++  Within  05  working  days  from  the  date  of  receiving  the  clinical  trial  change  approval  certificate  from  the  National  Ethics  Committee  and  the  accompanying  dossier,  the  Ministry  of  Health  grants  approval  for  the  clinical  trial  changes.

+ For changes specified in point b, clause 3, Article 102 of Decree 96/2023/ND-CP: within 07 working days from the date of receiving the valid dossier, the Ministry of Health of Vietnam grants the clinical trial change approval.

- Process and procedure for approval of clinical trial results:

+ The facility conducting the clinical trial submits directly, online, or by mail one application dossier requesting clinical trial result approval in Vietnamese to the Ministry of Health of Vietnam;

+ The Ministry of Health of Vietnam reviews the validity of the dossier within 05 working days from the date of receipt. If the dossier is valid, within 02 working days, the Ministry of Health of Vietnam forwards the dossier to the National Ethics Committee for review. If the dossier is invalid, within 02 working days, the Ministry of Health of Vietnam must issue a notification with specific instructions for the facility to supplement the dossier.

The facility conducting the clinical trial is responsible for completing the dossier within a maximum of 60 days from the date of receiving the notification. Beyond this period, the clinical trial result approval procedure must be restarted;

+ The National Ethics Committee conducts monthly periodic reviews and assessments of research ethics;

+ Within 05 working days from the date of receiving the clinical trial result approval certificate from the National Ethics Committee and the accompanying dossier, the Ministry of Health of Vietnam grants approval for the clinical trial results.

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