Ministry of Health grants circulation registration certificate for Russian anti-cancer drug

On November 11, according to information from the Ministry of Health , the Drug Administration of Vietnam granted a circulation registration certificate in Vietnam for an anti-cancer drug called Pembroria produced by Russia along with 13 other vaccines and biological products.

Accordingly, in Decision No. 628/QD-QLD of the Drug Administration of Vietnam, 14 vaccines and biological products were granted a registration certificate for circulation in Vietnam with a validity of 3 years (batch 57).

In the list attached to the above decision, 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.

Notably, according to information from the drug registration agency, 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...).

Along with the drug Pembroria, in this round of registration, there are also vaccines and medical biological products to treat stroke, lupus, osteoporosis, skin diseases, rheumatoid arthritis, ankylosing spondylitis, blood diseases, multiple sclerosis...

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.

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

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

(Vietnam+)

Source: https://www.vietnamplus.vn/bo-y-te-cap-giay-dang-ky-luu-hanh-cho-thuoc-chong-ung-thu-cua-nga-post1076341.vnp