UPDATED: Novartis Japan issued business improvement order by MHLW

Japan's Ministry of Health, Labor and Welfare (MHLW) said a business improvement order was issued to the Japan unit of Swiss-based Novartis ($NVS) on Nov. 13 for failing to report unspecified drug side effects on time, the third such sanction for the company in 18 months. A spokesman for the ministry told FiercePharmaAsia that Novartis did not report more than 5,000 side effect cases in specified timeframes. The company cited problems with its reporting protocols as the reason, the spokesman said, but the failure is still in violation of regulatory guidelines. A Novartis spokesman, in an email, said the switchover to a new reporting system caused the reporting delay and that it has been fixed. "The new system is now up and running normally," Novartis spokesman Eric Althoff said in the email. "Novartis is working closely with the MHLW to ensure that all data on all cases is being shared with Japanese authorities As of September 9 we are fully compliant and have no backlog of cases."