The Ministry of Health has newly issued and renewed nearly 600 drugs, including dozens of bioequivalent drugs.

Mr. Vu Tuan Cuong - Director of the Department of Drug Administration (Ministry of Health) said that the Department has just announced a list of nearly 600 types of drugs and pharmaceutical ingredients produced domestically and abroad that have been newly granted or have their circulation registration certificates extended in Vietnam.

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.

Along with that, 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.

Fully comply with Vietnamese laws and regulations of the Ministry of Health on drug production and circulation in Vietnam.

The Ministry of Health has newly issued and renewed nearly 600 drugs, including dozens of bioequivalent drugs...

At the same time, 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 adverse 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 Department 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.

It is known that domestically produced pharmaceutical products and pharmaceutical ingredients that have been newly granted or have their circulation registrations renewed this time are quite diverse in terms of pharmacological effects such as drugs for treating respiratory tract infections; drugs for treating osteoarthritis...; drugs for treating cardiovascular diseases, high blood pressure, diabetes, cancer treatment, antiviral drugs, antibiotics, pain relievers, anti-inflammatory drugs... Along with that, drugs with proven bioequivalence are also diverse in types.

Source: https://suckhoedoisong.vn/bo-y-te-cap-moi-gia-han-gan-600-thuoc-trong-do-co-hang-chuc-thuoc-tuong-duong-biological-nutrition-169251206123916227.htm