JAPAN

Regulatory and Ethical Procedures

Clinical trials must be conducted in accordance with GCP. Prior to conducting a clinical trial the sponsor has to ensure that all necessary non-clinical safety studies and other safety studies have been completed. Furthermore, the Ministry of Health, Labour and Welfare (MHLW) must be notified and the clinical trial protocol submitted. The MHLW is responsible for overseeing clinical trials and carrying out inspections at trial sites. The clinical trial may not be started until 30 days after the date of submission. Health Care System In Japan's health care system, employees are covered by the Employees' Health Insurance scheme and most of the rest of the population by the National Health Insurance scheme. Hospitals are to a great extent privately owned, but they are run on a non-profit basis. Authorities Ministry of Health, Labour and Welfare (MHLW)