von Tigerstrom Barbara
College of Law, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
Stem Cell Rev Rep. 2009 Jun;5(2):135-9. doi: 10.1007/s12015-009-9059-z. Epub 2009 Mar 4.
The recent approval by the United States Food and Drug Administration of a clinical trial involving a product derived from human embryonic stem cells, along with recent concerns about unproven stem cell therapies being offered to patients, highlight the importance of regulation at the critical stage of beginning human trials of novel therapies. The regulations governing therapeutic products (drugs and related products) are one part of the broader legal framework, but will play an increasingly prominent role as we move into clinical translation. The classification of products as drugs or biologics, on one hand, or minimally manipulated cell and tissue products for homologous use, on the other, will determine the requirements that will apply, including whether use in clinical trials requires approval. Product regulation works alongside other parts of the legal and policy framework, notably research ethics review and legal responsibilities of medical professionals, that play important though limited roles. Three key developments and challenges currently facing product regulation and related areas will affect stem cell research in this phase: regulatory reform, fragmentation, and capacity.
美国食品药品监督管理局最近批准了一项涉及源自人类胚胎干细胞的产品的临床试验，同时近期人们对向患者提供未经证实的干细胞疗法表示担忧，这凸显了在新型疗法开展人体试验的关键阶段进行监管的重要性。管理治疗性产品（药品及相关产品）的法规是更广泛法律框架的一部分，但随着我们进入临床转化阶段，其将发挥越来越突出的作用。产品被归类为药品或生物制品，或者另一方面被归类为用于同种使用的最低限度操作的细胞和组织产品，将决定适用的要求，包括在临床试验中的使用是否需要批准。产品监管与法律和政策框架的其他部分协同发挥作用，特别是研究伦理审查和医学专业人员的法律责任，它们发挥着重要但有限的作用。目前产品监管及相关领域面临的三个关键发展和挑战将在这一阶段影响干细胞研究：监管改革、碎片化和能力。
