Russian anti-cancer drug licensed for circulation in Vietnam

The Drug Administration of Vietnam ( Ministry of Health ) has granted a circulation registration certificate in Vietnam for the drug Pembroria with more than 14 indications for different types of cancer produced in Russia.

In which, Pembroria (main active ingredient is Pembrolizumab, content 100mg/4ml) is produced by Limited Liability Company "PK-137" (Russia). Registration facility: Anabion Pharmaceutical Trading Ltd, United Arab Emirates. Pembroria is prepared in the form of a concentrated solution for infusion, with a shelf life of 24 months from the date of manufacture. Packaging: 1 bottle x 4ml.

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

Decision 628/QD-QLD clearly states that drug manufacturing and registration establishments are responsible for: Producing and supplying drugs to Vietnam in accordance with the records and documents registered with the Ministry of Health .

The drug registration facility must report to the Ministry of Health on the maintenance of compliance with good manufacturing practices of the drug and drug ingredient manufacturing facility. In case the manufacturing facility has its manufacturing license revoked or fails to comply with good manufacturing practices of drugs and drug ingredients in the home country, the facility must make a report within 15 days from the date of notification by the competent management agency of the home country.

At the same time, coordinate with treatment facilities and preventive medical facilities to comply with current regulations on prescription drugs, monitor the safety, effectiveness, and unwanted effects of drugs on Vietnamese people, and synthesize and report according to regulations.

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

THIEN LAMB

Source: https://nhandan.vn/thuoc-chong-ung-thu-cua-nga-duoc-cap-phep-luu-hanh-tai-viet-nam-post922311.html