Among more than 500 drugs and generic drugs newly granted and renewed registration numbers by the Drug Administration of Vietnam this time, there are 414 domestically produced drugs.
News from the Ministry of Health on May 13 said that the Drug Administration has just extended the registration numbers for more than 500 drugs and specialty drugs for bidding and treatment.
Of these, 414 domestically produced drugs have had their registrations extended for 5 years (409 drugs) and 3 years (5 drugs). In addition, 68 generic drugs have been announced. This is the third announcement of generic drugs by the Ministry of Health since the beginning of the year.
There are 28 drugs and pharmaceutical ingredients with circulation registration certificates that can continue to be used according to the provisions of Clause 1, Article 3 of Resolution No. 80/2023/QH15 dated January 9, 2023 of the National Assembly . This is the 13th extension of the Ministry of Health to implement Resolution 80 of the National Assembly.
The original pharmaceutical products and brand-name drugs that have been newly granted circulation registration numbers and have had their registration numbers renewed in the past are quite diverse in terms of pharmacological effects, including drugs for treating cancer, cardiovascular disease, hypertension, diabetes, antiviral drugs, drugs for treating respiratory diseases, antibiotics, antipyretics, analgesics, other common anti-inflammatory drugs... and vaccines and biological products that are in high demand for use in medical examination and treatment and disease prevention.
The Ministry of Health requires that drug manufacturing and registration establishments are responsible for manufacturing drugs in accordance with the records and documents registered with the Ministry of Health and must print the registration number issued by the Vietnamese Ministry of Health on the drug label.
Manufacturing establishments are only allowed to manufacture and circulate specially controlled drugs when they have a Certificate of eligibility for pharmaceutical business. The scope of business of specially controlled drugs is suitable for the scope of operation of the establishment, meeting the provisions of Clause 5, Article 143 of Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government detailing a number of articles and measures to implement the Law on Pharmacy.
Previously, in March and early April 2024, the Ministry of Health issued new, extended and announced thousands of domestically produced drugs, generic drugs and drugs and pharmaceutical ingredients to implement Resolution 80 of the National Assembly (12th extension announcement).
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