Japan’s Kyowa Kirin, which recently won approval in the U.S. of a drug for Parkinson’s disease, says it is putting quality assurance and pharmacovigilance front and center.
Under a company reorganization that takes effect Jan. 1, the company has created quality and pharmacovigilance divisions that will report directly to the CEO, Kyowa Kirin announced (PDF) today.
As part of the reorg, it is establishing quality assurance and regulatory audit departments that will be part of the quality division. It said the changes were made to clarify roles and responsibilities and to pursue maintenance and improve the quality of the drugs it makes.
The changes come three months after Kyowa Kirin won FDA approval of Nourianz, which had been rejected by the FDA more than a decade ago. The drug has been sold in Japan since 2013 but was turned away by the FDA in 2008 over concerns about its efficacy.
Last year, another unit of Kirin Holdings, Kyowa Hakko Bio, had a plant in Yamaguchi, Japan, slapped with a warning letter after managers acknowledged workers manipulated data to get passing results when out-of-specification results appeared during testing.