Deciding whether to grant permission through a triple consultation procedure
The results of the first advisory group meeting will be released on the 18th.
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Ministry of Food and Drug Safety Celltrion (068270)An advisory group meeting will be held to verify the results of clinical trials of’Rekironaju’, an antibody treatment for a novel coronavirus infection (Corona 19) in Korea.
The Ministry of Food and Drug Safety announced on the 14th that it will hold a meeting of the’Corona 19 Treatment and Vaccine Safety and Effectiveness Verification Advisory Group’ (hereinafter referred to as the Verification Advisory Group) on the clinical trial data of Rekkirona. The results will be released on the 18th.
Corona 19 treatments and vaccines are decided on approval through a process of consulting an external expert in’triple’. The verification advisory group, the central pharmacist review committee (central pharmacy review committee), and the final review committee are in order. The verification advisory group meeting is the first step in the expert consultation process.
30 experts focused on infectious medicine will participate in the verification advisory group. This meeting will discuss whether the clinical trial results are appropriate to acknowledge the therapeutic effect of this drug. Celltrion announced that the administration of Rekironaju to mild and moderate Corona 19 patients the previous day reduced the recovery period by more than 3 days and reduced the incidence of severe patients by 54%.
After the verification advisory group meeting, opinions are sought from the Central Pharmaceutical Affairs Advisory Committee, an advisory body of the Ministry of Food and Drug Safety. The advisory committee for the Central Pharmacopoeia is composed of about 15 members, including standing members of the Biological Drug Subcommittee. This section deals with the issues discussed by the verification advisory group and its clinical usefulness.
After that, the Ministry of Food and Drug Safety holds a final inspection committee in which 10 internal and external experts participate in joint participation to determine the final permission. A final review will be conducted based on the results of the verification advisory group and the central pharmacy review committee.
/ Reporter Joowon Lee [email protected]
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