'No Disruptions in COVID-19 Vaccine Shipments'... MFDS Establishes Dedicated Team

Kim Gang-rip, Commissioner of the Ministry of Food and Drug Safety, is giving a briefing on the AstraZeneca COVID-19 vaccine approval on the afternoon of the 10th at the MFDS conference room in Cheongju, Chungbuk.
[Image source=Yonhap News]

[Asia Economy Reporter Lee Chun-hee] The Ministry of Food and Drug Safety (MFDS) will establish an organization to expedite the release of COVID-19 vaccines.

On the 16th, the MFDS announced that it will issue a legislative notice for the "Partial Amendment to the Enforcement Rules of the Ministry of Food and Drug Safety and Its Affiliated Agencies," which includes the establishment of a New Infectious Disease Vaccine Evaluation Division within the National Institute of Food and Drug Safety Evaluation. This is a temporary organization aimed at the rapid national release approval of COVID-19 vaccines.

The newly created New Infectious Disease Vaccine Evaluation Division will add 23 personnel, including one Grade 4 official, eight research officers, and fourteen research assistants. Although there is already a Vaccine Evaluation Division within the National Institute of Food and Drug Safety Evaluation, this dedicated team is being temporarily established to smoothly carry out the COVID-19 vaccination scheduled to begin in just 10 days.

Vaccines must undergo a national release approval process to verify quality before distribution, separate from product approval. Currently, AstraZeneca's COVID-19 vaccine received product approval from the MFDS on the 10th. The quarantine authorities plan to start COVID-19 vaccinations on the 26th, beginning with workers at long-term care hospitals, followed by residents and workers under 65 years old at long-term care hospitals and facilities. The national release approval process for this is currently underway.

In addition, through this amendment, the MFDS will increase personnel by seven for safety management of quasi-drugs such as masks, establish a new evaluation division within the Medical Device Safety Bureau to operate the Expert Committee on In Vitro Diagnostic Medical Devices, and add four personnel. Furthermore, seven personnel will be added to support on-site inspections of overseas pharmaceutical manufacturing sites.

Organizations or individuals with opinions on this amendment can submit their comments online through the integrated legislative notice system or send written opinions to the Ministry of Food and Drug Safety by the 17th.

This content was produced with the assistance of AI translation services.