Clinical Trial Review and Approval in Vietnam

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Dr. Trong Toan Nguyen
Medical Doctor, Vice Deputy
Department of Disease Control and Prevention,
Pasteur Institute in Ho Chi Minh City,
Vietnam

Clinical trial activities in Vietnam are standardized since 2007 with the FDA collaboration in GCP training. Two years later, the EC-MOH was recognized by OHRP. WHO recognizes NRA to Vietnam since 07/2015 also.

There are several regular, circular, decision were issues since 2008 up to now. These will be renew this year based on new drug law 2016.

CTs activities are submitted and approved by MOH. A new vaccine clinical trial’s submission included 2 reviews by IRB (at hospital/institution level) and EC MOH currently. For IRB, it takes at least 1 months from submit to the approval and for EC, it takes at least 60 working days. CRO of vaccine trial is strong recommend.

The package submission to IRB and EC are compliance to GCP guideline for essential documents. For vaccine trial, EC recommend to have CRO to take care and monitor the trial on behalf of sponsor

Up to know, there are 3 Institutions can perform a vaccine trial and the Clinical Research Center of PIHCM is the leading of vaccine trial central site in Vietnam.

The content is authorized by Dr. Trong Toan Nguyen on October 29, 2017.