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Imported orphan drug specimen storage standards

By Lee, Hye-Kyung | translator Kim, Jung-Ju

23.06.21 08:58:14

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The Ministry of Food and Drug Safety (Minister Oh Yoo-gyeong) announces a legislative announcement on the 21st of the amendment to the 'Rules on Safety of Pharmaceuticals, Etc. and, comments are accepted until August 21st. The main contents of this revision are ¡ã rationalization of sample storage standards for importers of imported orphan drugs ¡ã allowing companies applying for national release approval to directly collect and submit samples for testing ¡ã operation of the number of samples approved for national release, processing deadlines, and inspection items in the form of public notice. Currently, all pharmaceuticals must keep a sample volume that can test the test items specified for each product more than tw

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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