Policy for Supply of Unlicensed Medicinal Product for the Treatment
Shionogi & Co., Ltd. and subsidiary companies (hereafter Shionogi) are committed to developing safe and effective medicines and treatments for patients worldwide. Shionogi is responsible for conducting clinical trials to determine whether unlicensed medicinal products (investigational drugs) are safe and effective for treating a specific disease or condition before seeking regulatory approval to market these medicines. In addition, Shionogi may be able to supply the unlicensed medicinal product for the treatment in question following the regulatory process outside of a clinical trial, when meeting the three conditions below;
- Patient has a serious or life-threatening disease and no alternative treatments are available.
- Patient's condition is not eligible to enroll in a clinical trial sponsored by Shionogi.
- The patient’s physician determines the patient could potentially benefit from access to the unlicensed medicinal product before it is approved by a regulatory agency.
The request directed to Shionogi must be in writing, must be signed and submitted by a licensed physician who is in a treatment relationship with the patient for whom the unlicensed medicinal product is being requested. Shionogi does not guarantee it can or will approve access to such unlicensed medicinal products pursuant to the request as it has to evaluate several factors such as the total amount of available unlicensed medicinal products stocked. Shionogi may require up to five (5) business days to acknowledge and/or review the request.