The approval requirements for advanced treatment hospitals were revised to strengthen medical safety measures, making the compliance to system maintenance and introduced processes related to unapproved new drugs compulsory. Based on this, the Department of Unapproved New Drugs and Medical Devices Evaluation was established under the Department of Performance Monitoring and Risk Management.

We attempt to strengthen medical safety management with the appointment of a medical safety manager as the department head, and a drug safety manager as the department’s deputy-head. The rest of the department is composed of personnel in charge of medical equipment safety management, general risk managers and others.

The department determines the suitability of providing treatments employing drugs and medical devices that have not obtained approval or certification. When making a decision, the Unapproved New Drugs and Medical Devices Evaluation Committee will convene to exchange opinions. Moreover, the screening results by the Novel Therapies Exploratory Committee of the Graduate School of Medicine and Faculty of Medicine will also be taken into account when research interests are involved.

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