This is a notable content mentioned by the Minister of Health in Circular 26/2019/TT-BYT stipulating the List of Rare Drugs.
According to the provisions of Article 4 of Circular 26/2019/TT-BYT, the development of the List of Orphan Drugs must be based on the following principles:
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- Based on diagnostic and treatment guidelines, technical professional procedures issued by the Ministry of Health, the World Health Organization (WHO), reference regulatory agencies (including: European Medicines Agency (EMA), USA, Japan, UK, Switzerland, Australia) or reputable medical associations domestically, regionally, or globally (including: Vietnam Heart Association; Asian and European Liver Association; American College of Rheumatology and European League Against Rheumatism; European Society of Cardiology; American Heart Association; American Association of Clinical Endocrinologists, American Diabetes Association, and other reputable medical associations).- Review, inherit previously issued lists of orphan drugs according to regulations of the Minister of Health.- Refer to regulations on classification of rare diseases, classification, and the list of orphan drugs from the World Health Organization, reference regulatory agencies, and other relevant regulatory agencies.
The List of Orphan Drugs issued in the Appendix attached to Circular 26/2019/TT-BYT includes the List of Drugs for the prevention, diagnosis, and treatment of rare diseases and the List of Non-Available Drugs.
View the full text of the regulation at Circular 26/2019/TT-BYT effective from October 15, 2019.
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