Of the nearly 800 drug and pharmaceutical ingredients newly granted or renewed their circulation registration certificates by the Drug Administration, 432 domestically produced drug products were newly granted circulation registration certificates; 69 domestically produced drugs were granted extended circulation registration certificates; 292 foreign drugs were granted circulation registration certificates and 4 drugs with bioavailability were granted extension certificates.
Of the 432 domestic drug products newly granted circulation registration certificates, 422 drugs were granted circulation registration certificates for 5 years; the remaining 10 products were granted circulation registration certificates for 3 years;
Of the 69 domestically produced drugs whose circulation registration certificates have been extended, 44 drug and pharmaceutical ingredients have been granted a certificate of circulation extension for 5 years; 20 drug and pharmaceutical ingredients have been extended for circulation for 3 years; the remaining 5 products have a circulation extension value until December 31, 2025;
Of the 229 foreign drugs granted an extension certificate for circulation at this time, 187 drugs are granted a 5-year extension; 38 drugs are granted an extension for 3 years and 1 drug product is granted an extension until December 31, 2025.
The Department of Drug Administration requires drug manufacturing facilities and drug registration facilities to be responsible for producing drugs in accordance with the records and documents registered with the Ministry of Health and must print or stick the registration number issued by the Ministry of Health of Vietnam on the drug label;
Only special control drugs can be produced and put into circulation when there is a Certificate of eligibility for pharmaceutical business, especially in accordance with the scope of operations of the facility that meets the provisions of Article 37 of Decree No. 163/2025/ND-CP dated June 29, 2025 of the Government detailing a number of articles and measures to organize and guide the implementation of the Pharmacy Law;
At the same time, implement the updated drug quality standards according to the provisions of Circular No. 30/2025/TT-BYT dated July 1, 2025 of the Minister of Health guiding the application of quality standards, testing drugs, drug ingredients and recalling and handling violating drugs;
Update drug labels and drug use instructions according to the provisions of Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health regulating the labeling of drugs, drug ingredients and drug use instructions in the form of changes and supplements to drug circulation registration certificates prescribed in Circular No. 12/2025/TT-BYT dated May 16, 2025 of the Minister of Health for drugs that have not updated the content of drug labels and drug use instructions according to the provisions of Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health;
The Drug Administration of Vietnam requires drug registration establishments to ensure the maintenance of pharmaceutical business conditions as prescribed in Point b, Clause 2, Article 42 of the Pharmacy Law within the validity period of the drug registration certificate, pharmaceutical ingredients...
Domestic and foreign-made drug products that have been newly granted and have their circulation registration renewed this time are quite diverse in their group of pharmacological effects such as the group of drugs for treating respiratory infections; drugs for treating osteoarthritis...; cardiopulmonary drugs, hypertension, diabetes, cancer treatment, antiseptic drugs, antibiotics, painkillers, anti-inflammatory drugs... biological equivalent drugs...
