Related Technical Departments
The Clinical Development Division, formerly the Clinical Development Center, was incorporated into the Pharmaceuticals & Medical Products Division in 2007. In 2011, it established the CMC Division* to promote the global development of pharmaceuticals. Aimed at providing specialized handling of the clinical development of pharmaceuticals and medical devices, the Clinical Development Division and related technical department are comprised of the following departments.
* CMC: Chemistry, Manufacturing and Control
Pharmaceutical Clinical Research Dept.
The department active in clinical development of new pharmaceuticals, as well as new applications and formulations of previously approved drugs. It is also consigned with the work of obtaining approval from Japan's Ministry of Health, Labour and Welfare and overseas regulatory authorities to proceed with product sales.
Clinical Data Science Dept.
This department handles analysis, evaluation, reporting, and management related to the efficacy and safety of clinical trials.
Pharmaceutical CMC Promotion Dept.
This department creates CMC-related development strategies and plans for promoting the global development of pharmaceuticals, and prepares and manages application-related materials.
Pharmaceuticals Technical Development Dept.
This department is responsible for manufacturing based on GMP standards for drug substances and formulations used in both non-clinical trials and clinical development, as well as approval applications and the technologies necessary to make the shift to full-fledged production.
Medical Devices Clinical Research Dept.
This department is responsible for the clinical development of medical devices that can be considered new or improved medical devices (with clinical data). In conjunction with the Medical Devices Technical Dept., it is also tasked with obtaining approval from Japan's Ministry of Health, Labour and Welfare and overseas regulatory authorities to proceed with the manufacture and sale of products.
Medical Devices Technical Dept.
This is the core department in Toray's technology development of medical devices in areas including dialyzers for chronic renal failure and endotoxin adsorption columns for critical care, as well as catheters and contact lenses. As such, it handles manufacturing technology development ranging from design development to improving Toray's ability to add production sites.
- Moisture-type artificial kidneys that aim to improve host compatibility and dialysis functions through membrane surface improvement technologies focused on absorbed water
- REMITCH® selective κ-opioid receptor agonist, for the first time an oral drug to treat itching in hemodialysis patients that is resistant to existing treatments
*REMITCH® is a registered trademark of TORII PHARMACEUTICAL CO., LTD.
- CARELOAD® LA orally administered prolonged-release prostacyclin (PGI2) derivative
- TORAYMYXIN® is an extracorporeal hemoperfusion cartridge to remove endotoxin which is considered to be the serious pathogenic substance causing sepsis.