Publication of Criteria for Selecting Medicines for the List of Unavailable Medicines

17:28, 10/07/2024

Recently, the Ministry of Health issued Circular 26/2019/TT-BYT regulating the List of Rare Drugs.

In which there is a regulation that a drug can be considered for selection into the List of unavailable medicines when in Vietnam there are no other drugs available that can be substituted or if the drug has documented evidence proving significant benefits in terms of quality compared to other substitutable drugs on the domestic and international market and falls into one of the following cases:

- Drugs for the prevention, diagnosis, and treatment of diseases with a current case rate in a population at a given time not lower than 0.05% of the population and falls into one of the following categories: Genetic diseases; congenital diseases; cancer; autoimmune diseases;...;- Vaccines, diagnostic drugs, or preventive drugs with an estimated usage rate of not more than 8,000 cases per year in Vietnam;- Radiopharmaceuticals, markers;- The business of the drug does not generate sufficient profit to cover the cost of investment and marketing of the drug in the Vietnamese market.

See the detailed list of medicines at Circular 26/2019/TT-BYT effective from October 15, 2019.

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