Japanese Regulators Issue Order To Novartis on Side Effect Reports

Japan’s health ministry, in the first move of its kind, issued an improvement order to a drug company for failing to report information on side effects.

The order to Novartis Pharma, the subsidiary of the Swiss drug giant, is for failing to report serious side effects from patients’ use of its products. The charges were based on adverse effects attributable to the leukemia drugs sold under the brand names Gleevec and Tasigna.

There has never been a case where such administrative action was taken for delays in adverse drug reaction reports, Tetsuya Kusakabe, deputy director of the Compliance and Narcotics ...