China Solicits Feedback on Clinical Trial Quality Management Standard for FSMP
Aug 31, 2023
Sadie Shen
The applicant is responsible for the clinical trial.
All clinical trial records, whether in paper or electronic form, should be retained for a minimum of 5 years after the clinical trial concludes.
The draft refines the contents of protocols and final reports.
The scope of control sample is broadened.
On August 24, 2023, the State Administration for Market Regulation (SAMR) of China released an exposure draft of Clinical Trial Quality Management Standard for Foods for Special Medical Purpose (FSMP). The draft introduces substantial changes from the 2016 Trial Standard in areas like responsibilities of FSMP participants, timelines, definitions, and the content of protocols and final reports. Any comments can be submitted before September 24, 2023.
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