The 15-day suspension (detailed here in Japanese) will see Novartis Pharma K.K (NPKK) halt manufacture of drugs on March 5 and resume on March 19. The Swiss drugmaker’s unit will also have to stop selling drugs during the period.
In a statement emailed to in-Pharmatechologist.com Novartis said: “We can confirm that NPKK has received a 15-day business suspension order from the Ministry of Health, Labor and Welfare (MHLW) for failure to report adverse events within the timeline specified under the Law on Pharmaceutical and Medical Devices.
"The delay in reporting was confirmed following an internal review. The MHLW has not requested NPKK to revise product inserts or implement safety measures in relation to the delayed reporting of these adverse reactions. The suspension will start on March 5, 2015."
Details of drugs not impacted by the business suspension order will be posted on the NPKK and MHLW websites.
Novartis added: "For products that are in the scope of the order, the MHLW include mechanisms to ensure that patients continue to receive the treatments they need in an emergency, and NPKK will make every effort to minimize the impact on patients, physicians and pharmacists.
"We ask that patients contact their doctor and or pharmacist for advice should a necessary treatment indeed not be available."
Suspension warning
Novartis was informed of the likely suspension this month telling in-Pharmatechnologist.com Novartis Pharma KK received a pre-notification from the Ministry of Health, Labor and Welfare (MHLW) of a Business Suspension Order.
“NPKK will take all necessary steps to ensure that Japanese patients are not adversely affected by any proposed Business Suspension Order,” said Novartis.
“While we would need to evaluate the details of any proposed Business Suspension Order from the MHLW, we believe that the financial impact will be manageable.”
History
In February 2014, the MHLW accused Novartis of manipulating data for blood pressure drug Diovan and raided the company’s Tokyo office.
In June the firm told us it had taken steps to address the "clearly unacceptable practices."
This included "replacement of the local senior management team, third party review of investigator initiated trial programs and remedial training to ensure compliance with the company’s Code of Conduct."
But the problems continued in July when Novartis received a Business Improvement Order linked to the underreported side effects of leukaemia drugs Tasigna and Glivec.
An internal investigation found the company had blurred the lines between R&D and sales operations in Japan, and Novartis Sales staff had destroyed evidence about adverse effects of the drugs.
David Epstein, head of Novartis Pharmaceuticals, called the behaviour “unacceptable” and replaced the President of Novartis Holdings Japan and the heads of Japan’s pharma and oncology divisions.