Acting on a previous threat, the Japanese government has suspended Novartis’ pharmaceuticals operations in the country for breaching adverse effects reporting rules.

A spokesman for the Swiss drugs giant confirmed to PharmaTimes that Novartis Pharma KK (NPKK) has received a 15-day business suspension order from the Ministry of Health, Labor and Welfare for failure to report adverse events within the timeline specified under Japan’s Law on Pharmaceutical and Medical Devices. The suspension will run from March 5-19

He confirmed the delay was confirmed following an internal review. However he stressed that the MHLW has not requested NPKK “to revise product inserts or implement safety measures in relation to the delayed reporting of these adverse reactions”.
Novartis said it takes this matter “very seriously and we have been strengthening and expanding companywide measures to ensure that such incidences do not recur. NPKK will take all necessary steps to ensure that patients in Japan are not adversely affected by the business suspension”.
Based on its assessment of the details of the order, Novartis said it does not expect the suspension to have a material financial impact.