关于我国特殊医学用途配方食品监管引入真实世界证据的浅谈

Opinions on Introduction of Real World Evidence into Regulation of Food for Special Medical Purpose in China

近年,真实世界证据在药械监管领域的研究与应用日趋成熟,并取得了显著的成果。然而,真实世界证据在特殊医学用途配方食品领域的研究与应用鲜有提及。本文对真实世界证据在我国药械领域应用经验和成果进行总结,同时结合特殊医学用途配方食品在我国的监管情况进行讨论,供我国特殊医学用途配方食品监管领域引入真实世界证据参考。

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.