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与常规医药相比,纳米医药的质量控制仍存在许多问题。本文介绍了近期欧洲医药管理局(EMA)在纳米医药质量管理方面的进展。EMA在其一系列指导原则中,初步建立了适合纳米医药自身特点的安全性、有效性和稳定性评价方法,认为对于纳米医药,除考虑其化学成分外,还需额外考察其形态学特征(如尺寸、形状)以及表面特性等因素。并且在进行临床试验前,应先对其稳定性和生物等效性进行研究。我国监管机构在纳米医药的评价方面可借鉴EMA的相关措施。
Compared with conventional medicine, there are still many problems in the quality control of nanomedicine. This article describes the recent progress made by the European Medicines Agency (EMA) in nanomedicine quality management. In its series of guiding principles, EMA has initially established a safety, efficacy and stability evaluation method that is suitable for the characteristics of nanomedicine. It is considered that for the nanomedicine, in addition to considering its chemical composition, additional consideration needs to be given to its morphological characteristics Such as size, shape) and surface characteristics and other factors. And before conducting clinical trials, its stability and bioequivalence should be studied. China’s regulatory agencies in the evaluation of nano-medicine can learn from the EMA related measures.