Sudhop T
Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger Allee 3, 53175, Bonn.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2009 Apr;52(4):439-43. doi: 10.1007/s00103-009-0829-1.
The inclusion of compassionate use in the 14th amendment to the German Medicines Act offers the possibility to treat patients with not yet licensed medicinal products outside of clinical trials. The prerequisite for compassionate use is that a marketing authorisation application has been submitted for the medicinal product or that clinical trials with the medicinal product are still ongoing. Additionally, the medicinal product shall be administered only to patients suffering from a seriously debilitating disease or whose disease is life-threatening, and who can not be treated satisfactorily with a licensed medicinal product. The paper outlines the legal basis and available guidelines and discusses further aspects which may be relevant in compassionate use programs.
德国药品法第14次修正案中纳入的同情用药条款，为在临床试验之外使用尚未获得许可的药品治疗患者提供了可能性。同情用药的前提条件是，已提交该药品的上市许可申请，或者针对该药品的临床试验仍在进行中。此外，该药品仅应给予患有严重衰弱性疾病或其疾病危及生命，且无法通过已获许可的药品得到满意治疗的患者。本文概述了法律依据和可用指南，并讨论了同情用药计划中可能相关的其他方面。
