Under Kyowa’s current structure, which will remain in place until the start of next year, a combined pharmacovigilance and quality assurance division reports directly to Miyamoto.
This division sits above five subunits. One of the subunits handles quality assurance and another is focused on pharmacovigilance and quality assurance planning.
A regulatory audit subunit also serves the quality side of the operation. The remaining two subunits are focused on pharmacovigilance.
Starting next year, Kyowa will split the pharmacovigilance and quality assurance division into two standalone groups, both of which will have a direct line to the CEO.
The quality division will house two subunits focused on quality assurance and regulatory audits. Kyowa will divide the pharmacovigilance division up into subunits focused on business management, operations and medical matters.
In a statement to disclose the changes, Kyowa framed the reorganization as a way to clarify the roles and responsibilities of the quality assurance and pharmacovigilance functions.
The Japanese drugmaker also said the changes will enable it to set up and run a quality management system that supports the maintenance and improvement of product quality globally.
Kyowa’s interest in global product quality increased last year when it won marketing approvals for two products in the US and Europe. The company founded a global quality assurance committee to support quality and regulatory compliance last year but entered 2019 with more work to do.
Specifically, Kyowa planned to spend 2019 assessing standards at its manufacturing sites and talking to the teams that run them. In a policy that was updated in recent weeks, Kyowa stated there is still work to do on the quality strategy.
Kyowa wrote, “To manufacture and sell new in-house brand drugs in Japan, Europe and the US, we urgently need to build a PV & QA system that fulfills Good Practice (GxP) standards in each of these three regions. To this end, we are holding discussions at our global safety and quality committees composed of relevant managers at the head office and overseas subsidiaries, in light of our global policies for safety and quality matters.”
The changes are part of a wider reorganization designed to equip Kyowa to succeed in global markets. As part of the reorganization, Kyowa created a group responsible for North America that reports directly to its head office in Japan. Previously, the North American team reported to a Kyowa subsidiary in Europe that relayed the messages to Japan.