The Ministry of Health has issued new or renewed marketing authorization certificates for nearly 800 types of drugs.
The Drug Administration of Vietnam has recently granted new licenses and renewed licenses for nearly 800 types of drugs and pharmaceutical raw materials, both domestic and imported, to meet the needs of treatment and disease prevention.
On August 22nd, the Drug Administration of Vietnam (Ministry of Health) announced the list of nearly 800 types of domestically and internationally produced drugs and drug raw materials that have been newly granted or had their registration certificates renewed in Vietnam to serve the needs of treatment and disease prevention.
Accordingly, 432 domestically produced pharmaceutical products were newly granted marketing authorization; 69 domestically produced drugs had their marketing authorization renewed; 292 foreign drugs were granted marketing authorization renewals; and 4 drugs with proven bioequivalence were granted renewals.
Of the 432 newly registered domestic pharmaceutical products, 422 were granted registration certificates for 5 years; the remaining 10 products were granted registration certificates for 3 years.
Of the 69 domestically produced drugs whose marketing authorization was renewed, 44 drug products and drug raw materials were granted a 5-year renewal; 20 drug products and drug raw materials were granted a 3-year renewal; and the remaining 5 products have their marketing authorization valid until December 31, 2025.
Of the 229 foreign drugs granted registration renewals on this occasion, 187 drugs were renewed for 5 years; 38 drugs were renewed for 3 years, and 1 drug product was renewed until December 31, 2025.
The Drug Administration of Vietnam requires drug manufacturers and drug registration facilities to produce drugs in accordance with 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 may only produce and distribute specially controlled drugs when they have a Certificate of Eligibility for Pharmaceutical Business with a scope of business for specially controlled drugs that is consistent with their scope of operation.
The Drug Administration requires drug registration establishments to ensure they maintain the conditions for conducting pharmaceutical business as stipulated in point b, clause 2, Article 42 of the Law on Pharmaceuticals for the entire validity period of the drug and pharmaceutical raw material registration certificate...
The newly registered and renewed marketing authorizations for domestically and foreign-made pharmaceutical products this time cover a wide range of pharmacological effects, including: drugs for treating respiratory tract infections, drugs for treating osteoarthritis, drugs for treating cardiovascular diseases, hypertension, diabetes, cancer, antiviral drugs, antibiotics, analgesics, anti-inflammatory drugs, and bioequivalent drugs.../.
