www.mhlw.go.jp/stf/newpage_35815.html
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株式会社メディファーマによるＧＣＰ違反について｜厚生労働省
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https://www.mhlw.go.jp/stf/newpage_35815.html
About this page
This page is a press release from Japan's Ministry of Health, Labour and Welfare dated October 17, 2023, regarding GCP violations by Medifarma Co., Ltd. An inspection conducted from August 29 to September 4 identified multiple violations including data falsification, improper respiratory function testing, shared ID passwords among staff, and concealment of clinical trial drug storage deficiencies. The ministry instructed the company and trial sponsors to prioritize participant protection in ongoing trials. No health damage has been reported as of the announcement date.
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