Among the nearly 600 newly registered or renewed pharmaceutical products, pharmaceutical raw materials, and bioequivalence-certified drugs, 404 are domestically produced pharmaceutical products and 42 are domestically manufactured drugs; of which 26 drugs and pharmaceutical raw materials have their registrations renewed for 5 years; 14 drugs and pharmaceutical raw materials have their registrations renewed for 3 years; and 98 drugs with bioequivalence certifications have been officially announced.
The Drug Administration of Vietnam requires drug manufacturing companies to strictly adhere to the dossiers 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. They must fully comply with Vietnamese law and the regulations of the Ministry of Health regarding the production and distribution of drugs in Vietnam.
At the same time, drug manufacturing facilities must ensure that their operating conditions are met within the validity period of the drug and drug raw material registration certificate. They must 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 compile and report according to regulations...
Source: https://baodanang.vn/gan-600-loai-thuoc-nguyen-lieu-lam-thuoc-duoc-cap-moi-gia-han-giay-dang-ky-luu-hanh-tai-viet-nam-3314497.html






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