Renewal and issuance of more than 700 new drugs to serve patients

The Drug Administration of Vietnam, Ministry of Health has just extended the registration certificates for 700 domestically produced drugs; newly issued registration certificates for 41 drugs and newly issued and extended 21 registration certificates for vaccines and medical biological products.

Thus, the total number of drugs, vaccines and medical biological products newly granted or renewed circulation registration certificates by the Drug Administration of Vietnam is 762 types.

Of the 700 drugs that were renewed, 479 were renewed for five years, 193 were renewed for three years, and the remaining 28 were renewed until December 31, 2025.

Illustration photo.

Of the 41 newly granted drug registration certificates, 40 were granted new registration certificates within 5 years, and the remaining 1 was granted new registration certificates within 3 years.

Of the 27 vaccines and biological products whose circulation registration certificates were renewed or extended, 15 were renewed or newly granted for 5 years; 12 were renewed or newly granted for 3 years.

More than 700 new drugs, vaccines, and medical biological products have had their circulation registrations renewed this time, with a wide range of pharmacological effects... to serve the people's need for drugs and vaccines and for bidding and procurement.

Previously, the Ministry of Health had just extended 626 types of drugs, of which 425 were extended for 5 years, 156 were extended for 3 years and 45 were extended until December 31, 2025.

The types of drugs and generic drugs whose registration numbers have been extended in recent times are quite diverse in terms of pharmacological effects, including drugs for treating cancer, cardiovascular disease, hypertension, diabetes, antiviral drugs, drugs for treating respiratory diseases, antibiotics, antipyretics, analgesics, other common anti-inflammatory drugs... and vaccines and biological products that are in high demand for use in medical examination and treatment, and disease prevention.

According to the Drug Administration of Vietnam, as of May 2024, this agency has processed 666 drug import license applications, 3,641 applications for import licenses for raw materials, packaging, and capsules; announced 14 extensions of the validity of the circulation registration certificates for 13,202 drugs and pharmaceutical ingredients according to Resolution 80 of the National Assembly. Thereby, maintaining over 22,000 drugs with valid circulation registration certificates with about 800 active ingredients of all kinds.

The Ministry of Health requires that drug manufacturing and registration establishments are responsible for manufacturing drugs in accordance with the records and documents registered with the Ministry of Health and must print the registration number issued by the Vietnamese Ministry of Health on the drug label.

Specially controlled drugs may only be produced and circulated when there is a Certificate of Eligibility for Pharmaceutical Business. The scope of trading in specially controlled drugs must be consistent with the scope of operation of the facility that meets the regulations.

At the same time, update drug labels, drug instructions as prescribed and drug instructions within 6 months.

The Ministry of Health also requires drug manufacturing and registration establishments to coordinate with treatment facilities to comply with current regulations on prescription drugs, monitor the safety, effectiveness, and adverse effects of drugs on humans, and synthesize and report according to regulations.

Drug registration facilities must ensure that operating conditions are maintained during the validity period of the drug and drug ingredient circulation registration certificate.

In case the registration facility no longer meets the operating conditions, it must be responsible for changing the registration facility according to the provisions of Circular No. 08/2022/TT-BYT within 30 days from the date the registration facility no longer meets the operating conditions.

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.

Source: https://baodautu.vn/gia-han-cap-moi-them-hon-700-loai-thuoc-phuc-vu-nguoi-benh-d221626.html