Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Cytotherapy. 2018 Jun;20(6):779-784. doi: 10.1016/j.jcyt.2018.03.039. Epub 2018 May 18.
The development of standards for the field of regenerative medicine has been noted as a high priority by several road-mapping activities. Additionally, the U.S. Congress recognizes the importance of standards in the 21st Century Cure Act. Standards will help to accelerate and streamline cell and gene therapy product development, ensure the quality and consistency of processes and products, and facilitate their regulatory approval. Although there is general agreement for the need of additional standards for regenerative medicine products, a shared understanding of standards is required for real progress toward the development of standards to advance regenerative medicine. Here, we describe the roles of standards in regenerative medicine as well as the process for standards development and the interactions of different entities in the standards development process. Highlighted are recent coordinated efforts between the U.S. Food and Drug Administration and the National Institute of Standards and Technology to facilitate standards development and foster science that underpins standards development.
再生医学领域的标准制定已被多项路线图活动列为高度优先事项。此外，美国国会在《21 世纪治愈法案》中也认识到标准的重要性。标准将有助于加速和简化细胞和基因治疗产品的开发，确保工艺和产品的质量和一致性，并促进其监管批准。尽管人们普遍认为再生医学产品需要更多的标准，但为了在制定标准方面取得真正进展，以推进再生医学，需要对标准有共同的理解。在这里，我们描述了标准在再生医学中的作用，以及标准制定的过程以及标准制定过程中不同实体的相互作用。重点介绍了美国食品和药物管理局与国家标准与技术研究院之间最近为促进标准制定和支持标准制定所依据的科学而进行的协调努力。
