經(jīng)歐洲藥品管理局（European Medicines Agency，EMA）特殊審評(píng)通道上市的藥品在加速上市的同時(shí)，也需要接受更嚴(yán)格的上市后監(jiān)管。通過文獻(xiàn)分析的方法，在系統(tǒng)梳理相關(guān)法規(guī)和文獻(xiàn)的基礎(chǔ)上，對(duì)EMA特殊審評(píng)藥品上市后安全監(jiān)管體系及其特殊要求進(jìn)行了分析和介紹，并結(jié)合中國(guó)藥品審評(píng)審批改革和特殊審評(píng)藥品上市后監(jiān)管現(xiàn)狀，從管理理念、法規(guī)建設(shè)、上市許可持有人制度以及藥品再評(píng)價(jià)體系的建設(shè)和完善方面提出了政策建議。

Drugs are authorized through expedited review approaches by European Medicines Agency (EMA) with preferential policies which accelerated to the market, meanwhile, they should also accept stricter post-authorization regulation. This paper introduce and analyze the post-authorization policy requirements of drugs authorized through an expedited review approaches in EMA. Combined with the current situation of expedited review and relevant post-authorization monitoring policies in China, detailed suggestions were put forward with aspects includes the conceptual understanding of administration, establishment of the laws and regulations, the necessity of improving of the re-evaluation system, to improve the pharmacovigilance system in China.

R951

國(guó)家中醫(yī)藥管理局中醫(yī)藥行業(yè)科研專項(xiàng)（201507004）；國(guó)家食品藥品監(jiān)督管理總局保健食品審評(píng)中心保健食品原料目錄研究專項(xiàng)課題（ZBW-2017-BJSP-10）