Compassionate Use Programs are designed for patients who have a serious or urgent, life-threatening disease whose treatment has been unsuccessful with available medicinal products licensed by the Turkish Medicines and Medical Devices Agency (“Agency”) in Turkey and who cannot be included in the clinical trials on this subject. The Compassionate Use Program aims to provide the drug, which is not licensed in Turkey, but licensed or not in other countries, by the company that develops / supplies the drug for humanitarian reasons.
Regarding the scope and execution of the Compassionate Use Program, Guidelines on Compassionate Use ("Guidelines") and the annexes of the Guidelines is published on the website of the Agency.
On 31 December 2020, the Agency published a list ongoing Compassionate Use Programs in 2021 and updated this list on 12 February 2021.
In the published list, the Agency listed the Programs and the products to be supplied through these Programs, by mentioning the sponsor firm, required diagnosis, the firm that supplies the product, active ingredient of the product and the maximum number of patients to whom the product can be delivered. In addition, the products in the list are divided according to their indication areas including Dermatology, Infection, Haematology, Metabolism and Oncology.
First published by Gün + Partners, in 12.02.2021