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”.
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