REGULATORY

MHLW Won’t Order Novartis to Revise Package Inserts over Delayed ADR Reports, Urges Firms to Inspect Safety Control Regime

March 2, 2015
The Ministry of Health, Labor and Welfare (MHLW) on February 27 ordered Novartis Pharma to suspend its business for 15 days over its delayed adverse drug reaction (ADR) reporting, but the ministry said the penalty will not entail the revision…

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