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On-site inspections of overseas plants will resume next year

By Lee, Hye-Kyung | translator Choi HeeYoung

22.09.22 06:00:55

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The Ministry of Food and Drug Safety will prioritize new drug items that have never been subject to due diligence

Rare drugs and fast track targets are conducted non-face-to-face


On-site inspections of overseas biopharmaceutical manufacturing plants, which have been suspended due to COVID-19, will resume. The Ministry of Food and Drug Safety's Biopharmaceutical Quality Management Division recently sent an official letter to representatives of biopharmaceutical importers, the KOBIA, the KPBMA, Korea Pharmaceutical Traders Association, and the KRPIA to announce the pre-GMP site implementation of biopharmaceuticals.

Due to the prolonged COVID-19 situation, the Ministry of Food and Drug Safety revised the "Guidelines for Pre-GMP Evaluation of Biopharmaceuticals" on March 29 last year to convert overseas manufacturers that need on-site inspections into non-face-to-face inspections. N

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