China Updates the Clinical Trial Quality Management Standard for Foods for Special Medical Purpose

On May 11, 2024, China State Administration for Market Regulation (SAMR) released Clinical Trial Quality Management Standard for Foods for Special Medical Purpose (hereinafter “FSMP Clinical Trial Standard"), which applies to the clinical trial conducted for FSMP registration in China. This new regulation has been effective starting from the date of promulgation, and its previous trial version issued on October 13, 2016 has been repealed since then.

FSMP Clinical Trial Standard covers the whole process of quality control for FSMP clinical trial, including the scheme design, organization and implementation, data management and statistic analysis, the compilation of clinical trial conclusion and reports. The sample for trial should be manufactured according to the same formula, production techniques and product standard of the registered products, and align with corresponding national food safety standards or regulations. The production conditions should also comply with the Good Manufacturing Practice of FSMP.

Moreover, only agencies that meet specific criteria are authorized to carry out FSMP clinical trials. The detailed requirements are as below:

• The agencies should be equipped with clinical nutrition departments and professional departments related to the FSMP applied for registration.

• The agencies should possess organizational management capabilities, professional technical capabilities, ethical review capabilities, etc. to conduct clinical trials of FSMP.

• The agencies should have experience in clinical trials for drug registration.

• The agencies should be filed in the SAMR Special Food Verification and Evaluation Technical Institution Filing Information System.

The following are the key amendments compared with the 2016 version:

The clinical trial scheme design is further optimized

Considering the actual situation of clinical trials and the current industry landscape, the new version no longer specifies a minimum number of subjects or a fixed test period duration. The 2016 version required a minimum of 100 test samples and a test period of at least 7 days in principle. However, the revised standard removes these specific requirements and instead stipulates that the sample size and test period can be determined based on the disease types and test designs, provided they align with statistical principles.

The requirements for clinical trial scheme and report are detailed

According to the FSMP Clinical Trial Standard, the trial scheme should include basic information, research background, trial purpose, test design, and test management. The regulation further clarifies the requirements for these main sections. For instance, the basic information should consist of name, address, contact information of applicant, researcher, supervisors, data administrator, and statistical analysts, etc. By offering clearer instructions, the regulation aims to help enterprises improve the quality of their clinical trial reports.

The benefits of test subjects are reinforced

The 2024 version clarifies the responsibility of different parties, including the applicant, ethics committee, investigator, monitor and clinical trial agency. It explicitly states that these stakeholders should take necessary measures to safeguard the rights and well-being of individuals participating in the clinical trials. 

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