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공중보건 위기대응 의료제품의 개발 촉진 및 긴급 공급을 위한 특별법 고찰 및 FDA와 EMA의 유사 법안 비교 분석
김선영(Sunyoung Kim),한연경(YeonGyeong Han),문은희(EunHui Moon),강석연(SeokYeon Kang),강원구(Wongu Kang),원정우(Jeongwoo Won),정시연(Si-Yeon Jeong) 대한약학회 2022 약학회지 Vol.66 No.3
Since the outbreak of the new strain of coronavirus (SARS-CoV-2, COVID-19) was first reported, regulatory authorities worldwide have issued various regulatory guidelines and recommendations. Global authorities are committed to supporting developers of potential vaccines and treatments for COVID-19. This study reviewed the guidelines and regulatory procedures instituted by authorities in the United States and Europe to understand the current perspectives of regulatory agencies worldwide and derive implications for public health emergency responses. The Act on Encouragement of Development and Emergency Circulation of Medical Countermeasures for public health emergencies enacted in 2021 established 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 respect to medical countermeasures needed during public health emergencies. The FDA can also facilitate the use of those medical countermeasures. The EMA has accelerated regulatory procedures in place for expediting the development and approval of medicinal products for COVID-19. The EMA’s rapid procedure includes rolling review, accelerated assessment and conditional marketing authorisation. Based on the review of foreign policies and practices regarding public health emergencies, this study showed that the Act on Encouragement of Development and Emergency Circulation of Medical Countermeasures for public health emergency responses has made important advances in public health emergency preparedness and response.
아거수아모스,이재범,주신영,한연경,양정석,Agossou, Amos,Lee, Jae-Beom,Joo, Sin-Young,Han, Yeon-Kyeong,Yang, Jeong-Seoke Korea Water Resources Association 2024 한국수자원학회논문집 Vol.57 No.2
The study has examined alterations in groundwater quality by investigating the influence of rainfall on electrical conductivity (EC) and nitrate concentration in the groundwater of the Geum River Basin in South Korea. Mann Kendall and Sen's Slope estimator were employed to analyze the trends and estimate the trend's magnitude. The administrative map of the study area was utilized to assess the trends of these parameters within each administrative region. Seventeen years (from 2005 to 2021) of data on EC, groundwater levels (GWL), precipitation, and six years (from 2015 to 2020) of nitrate concentration data were utilized for this analysis. The results indicate that, in most administrative regions, there has been an increase in nitrate concentration, and EC, whereas precipitation has seen a slight decrease in a downstream and an increasing trend in upstream. The correlation coefficients calculated between these parameters reveal that there is no direct impact of precipitation on nitrate and EC, but a negative correlation was observed between GWL and EC. The most significant increasing trend in nitrate concentration was observed in two districts (Iksan and Gunsan ), which correspond to regions with significant agricultural activity; about 50% of these districts area are used for agricultural activities.