Novartis Japan ordered to shut down for failure to report side effects
wsj.com -- Feb 28
Health authorities ordered the Japanese unit of Novartis AG to shut down most operations for 15 days in March, saying the drug maker failed to report side effects from its products in a timely fashion.

The order by Japan’s Ministry of Health, Labor and Welfare, issued Friday, said Novartis Japan must halt production and sale of its drugs from March 5 to March 19. Five drugs were excluded from the order because of the potential harm to patients if supplies fell short.

The ministry said Novartis Japan failed to report 3,264 cases of side effects involving 26 drugs within the period required by law. It said the case was the first time the ministry had issued a suspension over failure to report side effects.

Novartis Japan said it accepted the punishment. It apologized to patients and doctors for “causing trouble and worry.” The company said that after reviewing the side-effect reports, it didn’t find any that would necessitate changing safety information on drug labels.

大手製薬会社「ノバルティスファーマ」が薬の重い副作用情報を国に報告していなかった­問題で、厚生労働省は27日、ノバルティス社に対し、15日間の業務停止命令を出しま­した。
News sources: wsj.com, TBS News-i
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