Arcturus corona 19 vaccine quality review, ‘The Ministry of Food and Drug Safety’s National Institute of Food and Drug Safety Evaluation will jointly participate in the review of Arcturus’ corona 19 vaccine item license evaluation by the European Medicines Agency (EMA).’,
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, ‘The vaccine is a product jointly developed by a U.S.-Australia pharmaceutical company using the next-generation mRNA platform. The Ministry of Food and Drug Safety officially became a participating institution in the OPEN program at the end of June this year, and this is its first official joint review participation.’,
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Oh Yoo-kyung, Director of the Ministry of Food and Drug Safety (Photo: Ministry of Food and Drug Safety),
, ‘The Ministry of Food and Drug Safety will evaluate the vaccine with various overseas advanced medicine regulatory authorities such as EMA through participation in the OPEN program, and plans to share expertise and global review criteria.’,
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, ‘Previously, the Ministry of Food and Drug Safety participated in joint reviews of several corona 19 vaccines through the OPEN pilot program in 2020.’,
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, ‘An official from the Ministry of Food and Drug Safety stated, “We will promote regulatory diplomacy to lead global regulatory harmonization, promote Korea’s excellent regulatory capabilities, and enhance global credibility,” adding that “we plan to actively support domestic medical products to smoothly enter the global market.”‘