Collection, evaluation and reporting of foreign safety information and CIOMS reports(<Special feature>Drug safety information collection)

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  • 国外安全性情報の収集・評価・報告とCIOMS報告書(<特集>医薬品安全性情報の収集)
  • 国外安全性情報の収集・評価・報告とCIOMS報告書
  • コクガイ アンゼンセイ ジョウホウ ノ シュウシュウ ヒョウカ ホウコク ト CIOMS ホウコクショ

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The person in charge of the foreign safety information on post-marketing drugs establishes and systemizes the methods of collecting information on the same ingredients of post-marketing drugs, including information on the measures taken by the regulatory authorities, adverse events and infectious disease derived from biological products obtained with literatures and academic meetings, and the CIOMS acquired from foreign affiliate companies. Collected information is evaluated primarily by the person in charge of the foreign safety information and secondarily at the Information Evaluation Study Group held weekly. Information judged at the Information Evaluation Study Group to be reportable is submitted to the Ministry of Health, Labour and Welfare within the reporting limited date of the information.

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