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Vietnam's Ministry of Health (MOH) recently issued the following requirements:
COVID-19 Decision
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Decision No. 3659/QD-BYT (August 21, 2020) -- guides research, clinical trials, registration for circulation, and use of the COVID-19 vaccine. Of note, this Decision reinforces the MOH’s ability to exempt certain clinical trial phases based on the recommendation of the Advisory Council, while still ensuring safety and efficacy for patients. (Google translation of Decision)
New Circulars
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Circular No. 10/2020 / TT-BYT - Regulations on Drug Bio Equivalence Trial (June 11, 2020) -- provides for the assessment of eligibility for drug bioequivalence testing facilities; guidelines for bioequivalence testing of drugs; and bioequivalence test documents and procedures of drugs.
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Circular No. 4 / TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (March 5, 2020) -- provides for the establishment, functions, duties, and powers of the National Ethics Committee in Biomedical Research (NECBR) and the Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL). This Circular also applies to ethics councils, agencies, organizations, and individuals conducting biomedical research activities related to human health in Vietnam.
The ClinRegs team will review these documents and incorporate them into the Vietnam profile where appropriate this year.
For details on all of Vietnam's clinical research regulatory requirements, view the country profile on ClinRegs.
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