The Ministry of Health announced a list of nearly 600 newly licensed and renewed drugs.

The Ministry of Health has just announced a list of nearly 600 drugs and pharmaceutical ingredients that have been newly granted or have their circulation registration certificates extended in Vietnam, to serve medical examination, treatment and epidemic prevention.

Medical staff dispense medicine. (Source: Vietnamplus)

Accordingly, among nearly 600 pharmaceutical products, pharmaceutical ingredients, and drugs with proven bioequivalence that were newly granted or had their registration and circulation certificates renewed by the Drug Administration of Vietnam this time, 404 domestically produced pharmaceutical products were newly granted circulation registration certificates; 42 domestically produced drugs had their circulation registration certificates renewed, of which 26 drugs and pharmaceutical ingredients were renewed for 5 years, and 14 drugs and pharmaceutical ingredients were renewed for 3 years. At the same time, 98 drugs with proven bioequivalence were announced.

The Drug Administration of Vietnam requires drug manufacturing companies to comply with the records and documents registered with the Ministry of Health and to print or affix the registration number issued by the Vietnamese Ministry of Health on the drug label; to fully comply with Vietnamese laws and regulations of the Ministry of Health on the production and circulation of drugs in Vietnam.

Drug manufacturing facilities must ensure the operating conditions of the manufacturing facility during the validity period of the drug and drug ingredient circulation registration certificate; coordinate with treatment facilities to comply with current regulations on prescription drugs, monitor the safety, effectiveness, and unwanted effects of drugs on Vietnamese people, and synthesize and report according to regulations.

Particularly for drugs whose circulation registration certificate has been extended but the application for updating the drug label and instructions for use has not been submitted as prescribed, the Drug Administration of Vietnam requires updating as prescribed in Point b, Clause 1, Article 37 of Circular No. 01/2018/TTBYT within 12 months from the date of extension of the circulation registration certificate.

In addition, drug registration facilities must ensure that operating conditions are maintained during the validity period of the drug and drug ingredient circulation registration certificate.

The domestically produced pharmaceutical products and pharmaceutical ingredients that have been newly granted and have their circulation registrations renewed this time are diverse in pharmacological groups such as drugs for treating respiratory tract infections; drugs for treating osteoarthritis; drugs for treating cardiovascular diseases, hypertension, diabetes, cancer treatment, antiviral drugs, antibiotics, pain relievers, anti-inflammatory drugs... In addition, drugs with proven bioequivalence are also diverse in types.

Source: https://baoquocte.vn/bo-y-te-cong-bo-danh-muc-gan-600-thuoc-duoc-cap-moi-va-gia-han-336822.html