[Asia Economy Reporter Lee Chun-hee] The Ministry of Food and Drug Safety (MFDS) is establishing a system to rapidly supply necessary medical products during public health emergencies such as COVID-19.
The MFDS announced on the 23rd that it has enacted and promulgated the "Enforcement Rules of the Special Act on the Promotion of Development and Emergency Supply of Medical Products for Public Health Crisis Response," which stipulates procedures and methods for priority review, emergency use authorization, and safety use measures.
These enforcement rules were prepared to define related matters following the enactment and implementation of the Special Act that creates a system for the urgent supply of medical products needed during public health crises. The rules include the operation of the Public Health Crisis Response Medical Products Safety Management and Supply Committee, procedures and methods for priority review and on-demand concurrent review, application methods for clinical trial support and MFDS support details, emergency use authorization procedures and methods, and safety use measures procedures and methods for those granted conditional product approval.
Accordingly, the Public Health Crisis Response Medical Products Safety Management and Supply Committee will be operated going forward. The term of committee members is two years, and members who have testified on the relevant agenda are disqualified. The committee may request opinions, data submission, and other information from heads of related institutions, corporations, organizations, or experts regarding deliberations.
Also, when a person designated as a preliminary public health crisis response medical product applies for product approval, a "priority review" will be conducted within 40 days from the date of application. Currently, for COVID-19 vaccines and therapeutics, the MFDS has drastically shortened the approval and review period from the previous six months to within 40 days, deciding approval through triple consultations with the Verification Advisory Group, Central Pharmaceutical Review Committee, and Final Inspection Committee.
The procedures and methods for on-demand concurrent review are also stipulated. When a person designated as a preliminary public health crisis response medical product applies for on-demand concurrent review, they must submit explanatory materials regarding the necessity of on-demand concurrent review for each product. If the MFDS director approves the on-demand concurrent review, an approval certificate will be issued within 20 days from the application date.
When designated as a preliminary public health crisis response medical product, national support for clinical trials will also be provided. Upon submission of a support application and a copy of the preliminary public health crisis response medical product designation certificate, support such as recruitment of subjects for clinical trials of the medical product will be provided.
Details on the emergency use authorization procedures and methods are also specified. When the head of a related central administrative agency requests the MFDS director for emergency use authorization of necessary medical products to appropriately respond to a public health crisis, the request must be made in writing specifying the reasons, target items, and usage period. At this time, clinical trial results and domestic and international approval status must be attached and submitted to the MFDS. When applying for conditional product approval after emergency use authorization, data related to usage performance must also be attached.
Currently, the MFDS is reviewing the emergency use authorization of the Novavax COVID-19 vaccine at the request of the Korea Disease Control and Prevention Agency.
After conditional product approval is granted, safety use measures evaluations will be conducted every six months for two years, and annually thereafter. Specific details of the measures must be prepared and distributed in the form of patient-use instructions. Additionally, those granted conditional product approval must submit a usage performance investigation plan one month before sales, and subsequently submit interim and final result reports within the designated timeframes.
An MFDS official stated, "We will continue to strive to promote the development and rapid supply of medical products to overcome public health crises such as COVID-19 vaccines and therapeutics. Furthermore, based on the experience and knowledge accumulated during the COVID-19 situation, we will do our best to improve public health through approvals and reviews grounded in expertise and regulatory science."
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