Nanomedicines Drafting Group, European Medicines Agency, 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK.
Nanomedicine (Lond). 2013 May;8(5):849-56. doi: 10.2217/nnm.13.68.
Over the last three decades many first-generation nanomedicines have successfully entered routine clinical use and it is now important for medicines regulatory agencies to consider the mechanisms needed to ensure safe introduction of 'follow-on' nanomedicine products, 'nanosimilars'. Moreover, drug regulators need to ensure that 'next'-generation nanomedicines enter clinical development and consequently the market in a safe and timely way for the benefit of public health. Here we review recent European Medicines Agency activities that relate to the effective development and evaluation of nanomedicine products while keeping patient and consumer safety at the forefront.
在过去的三十年中，许多第一代纳米药物已成功进入常规临床应用，现在对于药品监管机构来说，重要的是要考虑确保安全引入后续纳米药物产品（“纳米类似物”）所需的机制。此外，药品监管机构需要确保新一代纳米药物以安全且及时的方式进入临床开发和市场，从而使公众健康受益。在这里，我们回顾了欧洲药品管理局最近与有效开发和评估纳米药物产品相关的活动，同时将患者和消费者安全放在首位。
