[서울=뉴스핌] Reporter Seo Young-wook = The pharmaceutical authorities are entering into a three-step verification procedure for the effect of Celltrion’s’Rekironaju’, a Corona 19 antibody treatment.
The Ministry of Food and Drug Safety announced on the 14th that it will hold a meeting of the’Verification Advisory Group’ on the clinical trial data of Celltrion’s’Rekironaju’ on the 17th.
At the verification advisory group meeting, they are asked whether the clinical results of the clinical efficacy measurement index used in the clinical trial of Rekirona state and the principle of the drug operation are appropriate to acknowledge the therapeutic effect of this drug. The results will be released on the 18th.
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| [인천=뉴스핌] Reporter Jeong Il-gu = On the afternoon of December 22, the Celltrion novel coronavirus infection (Corona 19) antibody treatment’CT-P59′, which is undergoing clinical trials at Celltrion Plant 2 in Yeonsu-gu, Incheon, is being released. 2020.12.22 [email protected] |
In accordance with the Pharmaceutical Affairs Act, the Ministry of Food and Drug Safety is undergoing a procedure to seek advice from the Central Pharmacy Review Committee on matters regarding the safety and effectiveness of new drugs used. Consultation is conducted in the following order: ▲Verification Advisory Group ▲Central Pharmacy Review Committee ▲Final Inspection Committee.
The verification advisory group is a procedure for the Ministry of Food and Drug Safety to collect advisory opinions on areas such as clinical, non-clinical, and quality from various experts before consulting the Central Pharmacy Review Committee.
A pool of experts has been formed in advance, including about 30 experts in infectious medicine-focused clinical experts, non-clinical, quality, and clinical statistics, and an advisory group meeting with experts in the field is held according to the agenda.
The Central Pharmaceutical Affairs Review Committee is an advisory body for the Ministry of Food and Drug Safety pursuant to Article 18 of the Pharmaceutical Affairs Act, and advises on the safety, effectiveness, and matters to be considered when permitting the application.
The advisory committee consists of about 15 people, including standing members of the Biological Drug Subcommittee and related experts, and receives advice on matters discussed by the verification advisory group and clinical usefulness.
Prior to the final approval decision, the Ministry of Food and Drug Safety holds a’final inspection committee’ in which internal and external experts (around 10 people) jointly participate, and conducts a final inspection based on the consultation results of the verification advisory group and the central pharmacy review committee.
An official from the Ministry of Food and Drug Safety said, “We will collect various expert opinions in the process of reviewing approval for the treatment of Corona 19 and vaccines to ensure objectivity and transparency, while making thorough approvals and screenings possible.”