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The number of items has plummeted due to regulatory impact

By Lee, Tak-Sun | translator Choi HeeYoung

21.06.24 06:00:42

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In June, 63 registrations were issued and 226 were taken

Factors such as regulations on impurities and penalties for drug prices of entrusted items


Recently, More and more items are being removed due to the expiration date. Pharmaceutical companies have sorted out the items due to strong regulations on impurities and penalties for drug prices of consignment items. According to the MFDS on the 23rd, a total of 63 new drugs have been approved this month. On the contrary, there are 226 items which permits have been deleted, almost four times more. From January 1 to June 23 this year, 1,224 items were licensed. On the other hand, 2,229 items were deleted, nearly doubling.

Most of the deleted items have expired five-year period, and they have not submitted data that proves the safety and validity of the license renewal. Since 2018, the MFDS has operated

Lee, Tak-Sun(hooggasi2@dailypharm.com)
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