In its latest decision, the Drug Administration of Vietnam under the Ministry of Health has issued a marketing authorization for an anti-cancer drug named Pembroria, produced in Russia, along with 13 other vaccines and biological products.
Main Content
- Pembroria Drug Information
- Indications and Applications
- Cancer Situation in Vietnam
- Requirements and Responsibilities
According to Decision No. 628/QĐ-QLD dated October 31, signed by Mr. Vũ Tuấn Cường, Director of the Drug Administration of Vietnam, 14 vaccines and biological products have been granted marketing authorization in Vietnam for a validity period of three years (Batch 57).
Pembroria Drug Information
The accompanying list includes Pembroria (active ingredient: Pembrolizumab, concentration: 100mg/4ml), manufactured by Limited Liability Company "PK-137" (Russia) and registered by an establishment in the United Arab Emirates.
Pembroria is formulated as a concentrated solution for infusion preparation, with a shelf life of 24 months from the date of manufacture.
Indications and Applications
Notably, according to information from the registration establishment, Pembrolizumab has more than 14 indications for various types of cancer, such as non-small cell lung cancer, melanoma, colorectal cancer, cervical cancer, renal cell carcinoma, and breast cancer.
Current cancer treatments include surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, and other advanced drug generations.
Cancer Situation in Vietnam
Statistics from GLOBOCAN 2022 estimate that Vietnam recorded 180,480 new cancer cases and 120,184 cancer-related deaths. Leading types include breast cancer, liver cancer, lung cancer, and colorectal cancer, with incidence and mortality rates increasing annually.
Alongside Pembroria, the latest batch of marketing authorizations issued by the Drug Administration of Vietnam also includes vaccines and medical biologics for the treatment of conditions such as stroke, lupus, osteoporosis, skin diseases, rheumatoid arthritis, ankylosing spondylitis, blood disorders, and multiple sclerosis.
Requirements and Responsibilities
Decision No. 628/QĐ-QLD specifies that manufacturers and drug registration holders are responsible for producing and supplying medicines to Vietnam in accordance with the dossiers and documents registered with the Ministry of Health.
The registration holders must report to the Ministry of Health on maintaining compliance with Good Manufacturing Practices (GMP) at the drug and active ingredient manufacturing facilities. If the manufacturing facility has its production license revoked or fails to meet GMP standards in its home country, the registration holder must report this within 15 days from the date of notification by the competent authority.
Additionally, they must coordinate with treatment facilities and preventive healthcare institutions to comply with current regulations on prescription drugs, monitor safety, efficacy, and adverse reactions in Vietnamese patients, and compile and report data as required.
The Drug Administration of Vietnam also requires that, after receiving marketing authorization, companies must update the progress of Phase III immunogenicity clinical trials every three months from the date of approval and submit revised or supplementary data upon completion of the study.
(Source: suckhoedoisong.vn, baochinhphu.vn)