欧洲适应纳米医药特点的质量管理体系分析

Analysis of the quality control system suitable for nanomedicine in European

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。

In recent years,development of nanomedicine is very rapid. Some nanomedicines and medical devices using nanomaterials have already been approved into market. However,when compared with conventional medicines,quality control of nanomedicine has a lot of difficulties. For this reason,European Medicine Agency（ EMA） has initiated a series of working proposals on the issue of quality control as well as safety and efficiency evaluation on nanomedicine. Recent progress of EMA in the field of the quality control of nanomedicine was introduced in this paper via literature summarization. EMA has already built some initial evaluation methods of nanomedicine safety,efficiency and stability in its series of reflection papers. EMA considers that for nanomedicines,additional investigations on their morphological characters,such as size,shape,and surface properties,must be undertaken besides their chemical components. Researches on their stability and bioequiavailability must be carried out before clinical trial. Related measures of EMA can be learnt by regulatory authorities of our country.