In recent years,the research and application of Real World Evidence in the field of regulation of medical products and medical device have become increasingly mature and achieved significant results.However,the research and application of Real World Evidence in the field of formula food for special medical purpose are rarely mentioned.This article summarizes the experience and achievements of the application of Real World Evidence in the field of medical products and medical device in China,and discusses the regulatory situation of food for special medical purpose in China,so as to provide reference for the introduction of Real World Evidence in the regulatory field of food for special medical purpose in China.
关键词
真实世界证据/特殊医学用途配方食品/监管
Key words
Real World Evidence/food for special medical purpose/regulation