The Ministry of Food and Drug Safety will hold the Central Pharmacist Review Committee on the 27th to verify the safety and effectiveness of Celltrion’s novel coronavirus infection (Corona 19) treatment.
The Ministry of Food and Drug Safety completed a non-clinical investigation after completing a survey on the factory and medical institution of the celltrion treatment’Rekironaju’.·It was announced on the 21st that it has undergone additional review of clinical trial data and quality data review.
In order to confirm the safety and reliability of the test results of patients participating in the clinical trial, the Ministry of Food and Drug Safety reviewed documents and reviewed the regulations throughout the clinical trial, including writing patient consent, managing investigational drugs, and managing electronic data. Confirmed through on-site inspection.
The Ministry of Food and Drug Safety requested Celltrion to submit some quality data on the 20th, and it plans to continue its review when the data is submitted.
On the 27th, the review results are summarized and the results are scheduled to be disclosed to the’Central Pharmacy Review Committee’, a legal advisory body of the Ministry of Food and Drug Safety, on the safety, effectiveness, and considerations to be considered for approval.
The Ministry of Food and Drug Safety also said that it conducted an on-site survey from the 18th to the 20th at the SK Bioscience factory that consigns AstraZeneca vaccine, and is currently reviewing nonclinical and clinical trial data and quality data.
The Ministry of Food and Drug Safety compares and reviews the vaccination group and the placebo group to see if there is any safety information that requires special attention from the elderly over 65 years of age, and comprehensively reviews non-clinical and clinical trial data and reflects it in the precautions for use of the permit. I plan to do it.
The Ministry of Food and Drug Safety confirmed the management of electronically modified organisms and BSL (Biosafety Level) management of AstraZeneca vaccine, a virus vector vaccine that uses viruses, through a factory survey.
As the vaccine is a sterile injection, it was confirmed that the manufacturing area was equipped with facilities to prevent contamination from microparticles and microorganisms and maintained the specified cleanliness level. We also checked the actual manufacturing records and quality inspection records of the drug product and raw material stage, and reviewed the reliability of the data.
The Ministry of Food and Drug Safety requested AstraZeneca for non-clinical, clinical, and quality data necessary for screening for an additional 15 days. We will focus on the quality field evaluation
The’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Group’ meeting, in which external experts verify clinical trial data, will be held on the 31st, and the results will be released on February 1.