Director of the Department of Drug Administration (Ministry of Health) Vu Tuan Cuong has just signed a decision to issue a list of 14 vaccines and biological products granted a certificate of circulation in Vietnam.
The products licensed in this batch all fully meet the provisions of the 2016 Pharmacy Law, the Law amending and supplementing a number of articles of the 2024 Pharmacy Law, along with decrees and circulars guiding its implementation.
Production and registration establishments are responsible for: Producing and supplying according to the registered documents, printing the registration number issued by the Ministry of Health on the drug label.
Comply with Vietnamese laws on import and circulation of drugs; immediately report to the Drug Administration when there are changes in the circulation process in the host country or in Vietnam.
Report on maintaining good manufacturing practices (GMP); in case of revocation of the license or failure to comply with GMP, it must be reported within 15 days from the date of notification by the local management agency.
Coordinate with medical facilities to monitor the safety, effectiveness and adverse effects of drugs in Vietnam, and report periodically according to regulations.
In the licensed list, it is noteworthy that there is Pembroria (Pembrolizumab active ingredient, content of 100mg/4ml) - a cancer treatment drug manufactured by Liability Limited "PK-137" (Russia Federation) and Anabion Pharmaceutical Trading Ltd (united Arab Emirates) registered for circulation.
The drug is prepared in the form of a special solution for injection, with a shelf life of 24 months from the date of manufacture.
For Pembroria, the Drug Administration requires the company to update the clinical trial progress for phase III every 3 months and supplement data after completing the study.
The products licensed in this batch are mainly biotherapy products and advanced vaccines.
The Drug Administration of Vietnam said that this licensing is an important step in the strategy of expanding access to high-quality drugs, vaccines and biological products for Vietnamese people, while contributing to ensuring health security and diversifying the supply of drugs and vaccines in the context of increasing demand for disease prevention and treatment.
