Vietnam: What are the conditions for the organizations conducting clinical trial of new techniques?

07:35, 02/01/2016

This is a notable content specified in Circular No. 55/2015/TT-BYT regulating the recognition of clinical trial of new techniques and new methods in medical examination and treatment, which was issued on December 29, 2015 by the Ministry of Health of Vietnam.

According to Circular No. 55/2015/TT-BYT of the Ministry of Health of Vietnam, conditions for the organizations receiving clinical trial of new techniques and new methods in medical examination and treatment are specified as follows:

- Being a healthcare facility that has been granted a license to operate according to the regulations on medical examination and treatment; having a specialized scope of activities that aligns with the new techniques and new methods being tested.

- Having an Ethics Committee in Biomedical Research at the institutional level (hereafter referred to as the Ethics Committee), established by the head of the healthcare facility. The Ethics Committee shall have at least 5 members, including the Chairperson, Vice Chairperson, committee members, and the Secretary.

- Haing research personnel participating in the clinical trial who meet the conditions specified in Article 8 of this Circular.

View more details at Circular No. 55/2015/TT-BYT of the Ministry of Health of Vietnam, effective from February 16, 2016.

- Khanh Chi -

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