The Clinical Development Center was originally established in 1993 as the Health Care Products Development Division, and was subsequently renamed and upgraded to its current status in 1998. At present, the complex is comprised of the following four departments.
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, Labor and Welfare and overseas regulatory authorities to proceed with product sales.
The department assigned to conducting clinical trial data analysis and other key support operations.
The department responsible for developing manufacturing technologies 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.
The department in charge of clinical development for medical devices, artificial organs and other products for which basic studies have been completed by the Specialty Materials Research Laboratories and other arms of the Toray organization. It is also consigned with obtaining approval from Japan's Ministry of Health, Labor and Welfare and overseas regulatory authorities to proceed with product sales.
