MFDS Announces 2021 Government Work Report
[Asia Economy Reporter Kim Ji-hee] The Ministry of Food and Drug Safety (MFDS) announced on the 25th that it expects the approval of new coronavirus disease (COVID-19) vaccines and treatments to be completed by next month. In particular, the plan is to conduct vaccine approval reviews and national shipment approvals concurrently to reduce inspection time, enabling vaccinations within February.
The MFDS made this announcement through the 2021 work plans of the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, and the Korea Disease Control and Prevention Agency. The MFDS plans to support the emergency use of related medical products to achieve an early end to COVID-19, while strengthening management from clinical trials to distribution to ensure the safety of newly developed vaccines and treatments.
First, a dedicated review team for checking the safety and efficacy of vaccines and treatments has been formed to receive and review necessary documents prior to approval applications. Through this, the current review period of 180 days will be shortened to within 40 days, striving for early vaccine introduction.
At the same time, external expert consultations will be strengthened threefold to enhance the safety and effectiveness of the review process. In addition to the existing Central Pharmaceutical Review Committee, a Safety and Efficacy Verification Advisory Group and a Final Inspection Committee will be added.
The MFDS is currently conducting reviews for the COVAX Facility vaccine in response to the WHO's request for participation in the international joint review.
The government established the Pan-Governmental Support Committee for COVID-19 Treatment and Vaccine Development in April last year and plans to invest a total of 456.3 billion KRW in infrastructure development through this year. The goal is to develop treatments by February and vaccines within the year. Support for domestic vaccine and treatment development will continue. Currently, Celltrion's antibody treatment is undergoing approval review.
Risk management will also be strengthened step-by-step. In the clinical phase, it will be gradually mandated to regularly report all safety information starting with new drugs. From next month, preemptive prediction of post-market issues will be conducted through review of company test data and annual quality evaluations. During distribution, all stages of cold chain management will be tracked and monitored for adverse events, which will be transparently disclosed.
Follow-up measures after the use of vaccines and treatments will also be promptly established. By March, a pan-governmental damage investigation and compensation review system will be set up, and by June, procedures for rapid response to adverse events and causality verification will be prepared. Additionally, information on adverse events from major overseas countries will be monitored in real-time and disclosed transparently.
Furthermore, the MFDS will change the paradigm of food management in line with the recent trend of increasing online transactions. For delivery food, it plans to promote the indication of cooking time and attachment of sealing labels, and expand the exposure of hygiene grade information of restaurants on delivery apps. Online food sales sites such as Market Kurly will be obligated to manage food handling and storage.
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