Russian anti-cancer drugs are registered and licensed in Vietnam.

On November 11, the Drug Administration of Vietnam, Ministry of Health announced that it had just issued Decision No. 628/QD-QLD dated October 31 on 14 vaccines and biological products granted registration for circulation in Vietnam.

Among them, there is the drug Pembroria (main active ingredient is Pembrolizumab, content 100mg/4ml) produced by Limited Liability Company "PK-137" (Russia), registered by a facility in the United Arab Emirates.

Pembroria medicine is prepared in the form of a concentrated solution for infusion, with a shelf life of 24 months from the date of manufacture.

Pembrolizumab currently has more than 14 indications for different types of cancer (such as lung carcinoma, melanoma, colorectal cancer, cervical cancer, renal cell carcinoma, breast cancer...)

Pembroria medicine has the main active ingredient Pembrolizumab.

According to the Drug Administration, after being granted a circulation registration certificate, the company must periodically update the progress of clinical research on monitoring phase III immunogenicity every 3 months from the date of issuance of the circulation registration certificate. Submit documents to change and update data on monitoring phase III immunogenicity when the research period ends.

In addition to Pembroria, vaccines and biological products that have been granted circulation registration certificates include:

- Metalyse: Main active ingredient: Tenecteplase; Registration number: 400410440125

- Spevigo: Active ingredient: Spesolimab; Registration number: 400410440225

- Remsima: Active ingredient: Infliximab; Registration number: 400410440325

- Soliris: Active ingredient: Eculizumab; Registration number: 539410440425

- Flumist: Active ingredient: Live influenza vaccine (attenuated); Registration number: 001310440525

- Saphnelo: Main active ingredient: Anifrolumab; Registration number: 870410440625

- Darzalex SC: Active ingredient: Daratumumab; Registration number: 760410440725

- Ruxience: Active ingredient: Rituximab; Registration number: 540410440825

- Forsteo: Main active ingredient: Teriparatide; Registration number: 300410440925

- Ocrevus: Active ingredient: Ocrelizumab; Registration number: 400410441025

- Bemfola: Main active ingredient: RHFSH (follitropin alfa); Registration number: 500410441125

- Ziextenzo: Main active ingredient: Pegfilgrastim; Registration number: 900410441225

- Repatha: Active ingredient: Evolocumab; Registration number: 001410441325

The Drug Administration requires all units to be responsible for all drugs produced and supplied to Vietnam to comply with the records and documents registered with the Ministry of Health . Each product must have the registration number issued by the Ministry of Health printed or affixed to the drug label to ensure transparency and traceability.

These facilities must fully comply with Vietnamese laws and regulations of the Ministry of Health on the production, import and circulation of drugs. If there are any changes related to drugs during the circulation in the home country or in Vietnam, the facility must immediately report to the Drug Administration of the Ministry of Health.

For drug registration establishments, maintaining good manufacturing practices (GMP) of drug and raw material manufacturing establishments is mandatory. In case the manufacturing facility has its license revoked or no longer meets GMP standards in the home country, the drug registration establishment must report to the Ministry of Health within 15 days from the date of receiving the official notification, as prescribed in Article 98 of Decree 163/2025/ND-CP.

In addition, drug manufacturing and registration facilities need to coordinate with treatment facilities and preventive medical facilities to fully implement regulations on prescription drugs, monitor safety, effectiveness, and unwanted effects on Vietnamese people.

vov.vn

Source: https://baolaocai.vn/thuoc-chong-ung-thu-cua-nga-duoc-dang-ky-cap-phep-tai-viet-nam-post886566.html