2017年6月,原国家食品药品监督管理总局正式加入国际人用药品注册技术要求协调会(ICH),2018年6月,成为ICH管理委员会成员。本文从ICH的历史发展和改革、中国加入ICH及其管理委员会的历程、加入ICH后的工作和发展等方面进行了阐述,标志着我国药品标准在国际合作领域迈出重要的一步。从中折射出我国药品监管部门在融入国际规则制定机制中付出的艰辛努力和取得的巨大进步。
<<关键词: | 药品标准ICH国家食品药品监督管理总局 |
In June,2017,the former National Food and Drug Administration officially became a member of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). In June,2018,it became a member of ICH Management Committee. This report elaborated on the historical development and reform of ICH,the process of China’s entry into ICH and its management committee,and the work and development after joining ICH,which marked an important step of China’s drug standards in the field of international cooperation. It reflected the hard work and tremendous progress made by China’s drug regulatory authorities in integrating into the international rules-making mechanism.
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