Joint Research Centre, European Commission, Ispra, Italy.
Joint Research Centre, European Commission, Geel, Belgium.
Wiley Interdiscip Rev Nanomed Nanobiotechnol. 2019 Jan;11(1):e1531. doi: 10.1002/wnan.1531. Epub 2018 Jun 20.
Appropriate documentary standards and reference materials are crucial building blocks for the development of innovative products. In order to support the emerging sector of nanomedicine, relevant standards must be identified and/or developed before the products will enter into the regulatory approval process. The anticipation of standardization needs requires a good understanding on the regulatory information requirements that can be triggered by the particularities of nanomedicines. However, robust datasets allowing firm conclusions on regulatory demands are not yet available due to a lack of regulatory experience with innovative products. Such a catch-22 situation can only be advanced in an iterative process by monitoring continuously the scientific evidence and by promoting intensive knowledge exchange between all involved stakeholders. In this study, we have compiled information requirements released by regulatory scientists so far and mapped it against available standards that could be of relevance for nanomedicines. Our gap analysis clearly demonstrated that for some endpoints such as drug release/loading and the interaction of nanomedicines with the immune system no standards are available so far. The emerging nanomedicine sector could benefit from cross-sector collaboration and review the suitability of standards that have been developed for nanomaterials used for other industrial applications. Only a concerted action of all parties can lead to a smooth translation of nanomedicines to clinical application and to the market. This is in particular important because nanotechnology-based drug delivery systems are key for the development and implementation of personalized medicine. This article is characterized under: Toxicology and Regulatory Issues in Nanomedicine > Regulatory and Policy Issues in Nanomedicine.
适当的文件标准和参考资料是创新产品开发的重要基石。为了支持新兴的纳米医学领域，在产品进入监管审批程序之前，必须确定和/或制定相关标准。对标准化需求的预测需要对纳米药物特殊性可能引发的监管信息要求有很好的了解。然而，由于缺乏对创新产品的监管经验，目前还没有足够的数据集来确定监管需求，因此无法得出确定的结论。这种困境只有通过不断监测科学证据，并促进所有相关利益攸关方之间的密集知识交流，才能在迭代过程中得到推进。在这项研究中，我们已经整理了迄今为止监管科学家发布的信息要求，并将其与可能与纳米医学相关的现有标准进行了映射。我们的差距分析清楚地表明，对于一些终点，如药物释放/负载以及纳米药物与免疫系统的相互作用，目前还没有标准。新兴的纳米医学领域可以从跨部门合作中受益，并审查已为其他工业应用开发的纳米材料标准的适用性。只有所有各方的共同行动才能实现纳米医学向临床应用和市场的顺利转化。这一点尤其重要，因为基于纳米技术的药物输送系统是开发和实施个性化药物的关键。本文的特点是：纳米医学中的毒理学和监管问题>纳米医学中的监管和政策问题。
