Compassionate Treatment

The term "Compassionate Treatment" in English means showing sympathy and mercy.

"Compassionate Treatment", simply put, is a treatment aimed at severely ill patients, using therapies that have not yet been officially approved by the regulatory authorities.。

In April 2016, the Ministry of Health and Welfare officially renamed "Compassionate Treatment" to the "Regulations on Human Trials" and partially opened the application conditions for subsidiary proposals. This regulation was established earlier than the "Administrative Regulation on Special Medical Instruments and Inspection Techniques" and the "Draft Act on Regenerative Medicine and Regenerative Medicinal Products".
Article 3-1 of the Regulations on Human Trials: For the treatment of specific patients with life-threatening diseases or serious disabilities for which no effective drugs, medical devices, or medical technologies are available in Taiwan, a medical care institution may draft a subsidiary proposal for a human cell therapy trial that has been approved by the central competent authority and has accumulated a considerable amount of safety data, and may submit the same, together with a photocopy of the original human trial proposal approved, for review in accordance with Paragraph 3 of Article 78 of this Act. After approval by the Review Board, the institution may apply to the central competent authority for approval of using the drugs, medical devices, or medical technologies involved on patients who meet the indications but fail to meet the eligibility criteria for original human trial subjects.