Jurewicz Margin
Pol Merkur Lekarski. 2014 Dec;37(222):369-72.
The purpose of EU regulations in relation to nanotechnology, according to the European Commission's Communication "Regulatory aspects of nanomaterials", is to allow the public to use innovative applications of nanotechnology while ensuring a high level of safety, health care and environmental protection. This article characterizes and comments on EU legislation in respect of medicinal products containing nanomaterials. Medicinal products manufactured using nanotechnology are subject to the optional centralized authorization procedure by the European Commission authorizations for the placing on the market throughout the EU; advanced therapy medicinal products containing nanomaterials are covered by the mandatory centralized procedure. Evaluation of medicines in centralized authorization mode for the marketing of medicinal products, including those containing nanomaterials, is carried out by the Committee on Medicinal Products for Human Use (CHMP) subject to the European Medicines Agency (EMA).
根据欧盟委员会的《纳米材料监管方面》通讯，欧盟关于纳米技术的法规目的是允许公众使用纳米技术的创新应用，同时确保高水平的安全、医疗保健和环境保护。本文对欧盟关于含纳米材料药品的立法进行了描述和评论。使用纳米技术生产的药品需通过欧盟委员会的选择性集中授权程序，以在整个欧盟市场上市；含纳米材料的先进治疗药品则适用强制性集中程序。包括含纳米材料药品在内的药品上市集中授权模式下的药品评估，由隶属于欧洲药品管理局（EMA）的人用药品委员会（CHMP）进行。
