After decades of research, nanotechnology has been used in a broad array of biomedical products including medical devices, drug products, drug substances, and pharmaceutical-grade excipients. But like many great achievements in science, there is a fine balance between the risks and opportunities of this new technology. Some materials and surface structures in the nanosize range can exert unexpected toxicities and merit a more detailed safety assessment. Regulatory agencies such as the United States Food and Drug Administration or the European Medicines Agency have started dealing with the potential risks posed by nanomaterials. Considering that a thorough characterization is one of the key aspects of controlling such risks this review presents the regulatory background of nanosafety assessment and provides some practical advice on how to characterize nanomaterials and drug formulations. Further, the challenges of how to maintain and monitor pharmaceutical quality through a highly complex production processes will be discussed.

经过数十年的研究，纳米技术已被广泛用于各种生物医学产品中，包括医疗设备，药品，原料药和药用级赋形剂。但是，就像科学上的许多伟大成就一样，这项新技术的风险与机遇之间也可以达到很好的平衡。纳米级范围内的某些材料和表面结构会产生意想不到的毒性，并值得进行更详细的安全评估。美国食品药品监督管理局或欧洲药品管理局等监管机构已开始处理纳米材料带来的潜在风险。考虑到全面表征是控制此类风险的关键方面之一，本综述介绍了纳米安全性评估的监管背景，并就如何表征纳米材料和药物制剂提供了一些实用建议。此外，还将讨论如何通过高度复杂的生产过程来维持和监控药品质量的挑战。