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Vietnam's approval process and regulations for clinical trials

Jun. 22, 2017

As the importance of biomedical research grows in Vietnam, the government's scientific and ethical standards have become more stringent in an effort to provide a more comprehensive regulatory environment.

Simultaneously, the Vietnam Ministry of Health is working to expedite the regulatory approval process for clinical trials by providing comprehensive instructions on the requirements for documentation.

Submission of application dossier to register a clinical trial

Registration of a clinical trial requires the submission of a complete application dossier with the Administration of Science, Technology and Training of the Ministry of Health. The Ministry of Health responds within 15 working days with an approval letter, allowing the investigating organization to take next steps, or rejects the application.

Submission of product dossier

Submission of a product dossier and the clinical trial protocol to the Administration of Science, Technology and Training of the Ministry of Health comes after approval of the application dossier.

Upon receipt of the product dossier, two examinations are conducted. The first by the Science and Technology Council and the second by the Biomedical Research Ethics Council. Both are within the Ministry of Health.

The Science and Technology Council considers the scientific basis of the proposed trial, while the Biomedical Research Ethics Council examines the ethical aspects of the clinical trial.

Based on the results of these examinations, the Science and Training Department will request further supplementary documents if it deems the product dossier information to be insubstantial. If results are positive, it will forward the results to the Minister of Health for approval.

Requirements and conditions

Any investigating organizations seeking the registration of clinical trials must have qualified facilities, equipment and human resources to comply with Good Clinical Practice (GCP).

Only central level health institutes the Vietnam Ministry of Health directly manages are eligible to conduct clinical trials. Provincial level health institutes are only allowed to conduct clinical trials in Ho Chi Minh City.

All participation in clinical trials must be voluntary. Informed consent must be given by participants. If children, the mentally disabled, people living with HIV/AIDS, pregnant women and others with special conditions wish to volunteer for clinical trials, the Minister of Health must give consent first.

The advantages of clinical trials in Vietnam

Vietnam's large population is treatment-naïve, providing a vast pool of participants with diseases from both the developed and developing world at a rapid pace for clinical trials. Doctor -patient relationships are strong in Vietnam, and as a result, the retention rate for clinical trials is high.

Furthermore, a new law has been implemented by the National Assembly of Vietnam. In previous years, new foreign medicines had to go through clinical trials in their native countries before being circulated in Vietnam for further testing.

Under the new law, effective from January 1, 2017, this time- and resource-consuming requirement has now been waived (if the appropriate clinical data to support a medication's safety and efficacy can be provided).

The new law allows Vietnam to focus its time and resources on important clinical trials more efficiently.

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