Announcement (No. 48/2024) of the State Administration for Market Regulation (SAMR) on the Release of the Key Points and Determination Principles for On-Site Inspections of Clinical Trials for Special Medical Purpose Formula Foods.

This Announcement of the State Administration for Market Regulation (SAMR) on the Release of the Key Points and Determination Principles for On-Site Inspections of Clinical Trials for Special Medical Purpose Formula Foods outlines the framework for inspecting clinical trials related to the registration of foods for special medical purposes (FSMPs) in China.
The Text of the Key Points and Determination Principles for On-Site Inspections of Clinical Trials for Special Medical Purpose Formula Foods establishes clear guidelines for on-site inspections of clinical trials conducted for FSMP registration to ensure compliance with regulatory requirements, improve oversight, and maintain food safety and efficacy. It specifies criteria for determining whether a clinical trial meets regulatory standards. These include compliance with Good Clinical Practice (GCP), accurate documentation, and adherence to the approved protocol.