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KMID : 0370220220660030125
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Yakhak Hoeji
2022 Volume.66 No. 3 p.125 ~ p.139
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Public Health Emergency Preparedness and Response by Regulatory Authorities in South Korea, United States, and Europe
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Kim Sun-Young
Han Yeon-Gyeong
Moon Eun-Hui
Kang Seok-Yeon
Kang Won-Gu
Won Jeong-Woo
Jeong Si-Yeon
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Abstract
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Since the outbreak of the new strain of coronavirus (SARS-CoV-2, COVID-19) was first reported, regulatoryauthorities worldwide have issued various regulatory guidelines and recommendations. Global authorities are committed tosupporting developers of potential vaccines and treatments for COVID-19. This study reviewed the guidelines andregulatory procedures instituted by authorities in the United States and Europe to understand the current perspectives ofregulatory agencies worldwide and derive implications for public health emergency responses. The Act on Encouragementof Development and Emergency Circulation of Medical Countermeasures for public health emergencies enacted in 2021established the Ministry of Food and Drug Safety (MFDS) to oversee policies for public health emergencies. In the US,the Public Law 113-5, the PHS Act, the PREP Act and the FD&C Act grant authorities emergency use power with respectto medical countermeasures needed during public health emergencies. The FDA can also facilitate the use of those medicalcountermeasures. The EMA has accelerated regulatory procedures in place for expediting the development and approvalof medicinal products for COVID-19. The EMA’s rapid procedure includes rolling review, accelerated assessment andconditional marketing authorisation. Based on the review of foreign policies and practices regarding public healthemergencies, this study showed that the Act on Encouragement of Development and Emergency Circulation of MedicalCountermeasures for public health emergency responses has made important advances in public health emergencypreparedness and response.
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KEYWORD
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Ministry of Food and Drug Safety, Medical Countermeasures, Public health emergency, Emergency Use Authorization, Rapid procedure
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