MFDS Establishes New Division for Emerging Infectious Disease Vaccine Testing... "Accelerating Approval for COVID-19 Vaccine Shipment"
[Asia Economy Reporter Seo So-jeong] The Ministry of Food and Drug Safety (MFDS) is establishing a New Infectious Disease Vaccine Evaluation Division and expanding its workforce by 26 personnel to expedite the national batch release approval of COVID-19 vaccines.
On the 23rd, the MFDS and the Ministry of the Interior and Safety announced that they will increase the staff dedicated to the national batch release approval process to facilitate the rapid administration of COVID-19 vaccines.
National batch release approval is a system in which the government conducts an additional quality check to ensure the consistency, safety, and efficacy of biological products such as vaccines.
Currently, the Vaccine Evaluation Division within the MFDS is responsible for establishing testing methods and conducting national batch release approvals for existing vaccines like the flu vaccine. However, with limited organization and personnel, it has been challenging to establish testing methods and promptly approve the newly introduced COVID-19 vaccines.
Therefore, there has been a need to strengthen the organization and workforce to timely promote national batch release approval for COVID-19 vaccines and to swiftly handle testing method establishment for domestically developed vaccines in the future.
The New Infectious Disease Vaccine Evaluation Division will be newly established within the Biologics and Pharmaceuticals Evaluation Department of the MFDS. It will secure 26 new experts specialized in manufacturing and quality control fields such as immunology, biology, genetics, and advanced instrument analysis. This division will be responsible for national batch release approval and testing method review and establishment for new infectious disease vaccines including COVID-19 vaccines, establishment of national reference standards, development of standard testing methods, and quality inspection of distributed products.
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The MFDS stated, "Through this organizational and personnel expansion, we will conduct national batch release approvals quickly and meticulously for the newly introduced diverse and large quantities of COVID-19 vaccines, striving to ensure public health and safety."
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