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[Reporter¡¯s View] Reliability Verification Review Committee

By Lee, Hye-Kyung | translator Kang, Shin-Kook

24.06.20 05:01:25

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The Ministry of Food and Drug Safety has formed a Reliability Verification Review Committee. In the 'Guideline for Drug Manufacturing, Sales, and Import Marketing Authorizations and Labeling Change Authorizations,' which was revised by the MFDS on the 17th, a procedure was added for the Reliability Verification Review Committee to verify the reliability of the permit data submitted by companies during the drug approval and review process.

In the past, if data with questionable reliability was submitted during the approval and review process, nothing happened if the applicant withdrew the data. Unreliable data is data that is false or falsely presented data. In other words, if false data was submitted i

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