2016年11月16日,中国食品药品检定研究院(以下简称中检院)网站发布了《EV71疫苗质控和评价技术要点》。该技术要点为中检院第一个针对疫苗质控和评价方面具体技术规范的文件,详细阐述了我国创新性EV71疫苗生产和研发过程中的质量控制要点。解读该指导性文件的起草背景,明确其 On November 16, 2016, the website of China Food and Drug Administration (hereinafter referred to as CIQ) released the “Essentials of Quality Control and Evaluation of EV71 Vaccine”. This technical point is the first document issued by the CIQ to address the specific technical specifications for vaccine quality control and evaluation. The key points of quality control in the production and R & D of the innovative EV71 vaccine in China are described in detail. Understand the drafting background of the guidance document, make it clear