[關鍵詞]
[摘要]
美國食品藥品管理局(FDA)于2019年5月發(fā)布了“供企業(yè)用證明與參照藥可互換性考慮的問題的指導原則”(正式版本)。該指導原則介紹了FDA對治療性蛋白質產品與參照藥可互換性研究的原則要求和具體研究數據和信息的要求。而中國目前尚無類似指導原則。詳細介紹該指導原則主要內容,期望對我國這方面的研究和監(jiān)管能走在世界前列有所幫助。
[Key word]
[Abstract]
FDA issued the Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry (final) in May 2019. This guidance introduces the FDA's requirements on the principles and the specific research data and information of interchangeability between therapeutic protein products and reference products. There is no similar guidance at present in China. This paper introduces the guidance in detail, hoping that it will be helpful for our research and supervision in this field to lead the world.
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