China Solicits Feedback on Clinical Trial Quality Management Standard for FSMP

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.

Clearer Roles of FSMP Participants

The new draft provides more detailed breakdown of the responsibilities of FSMP participants compared to the 2016 Trial Standard. For instance, clinical trial organizations and investigators have responsibilities to manage investigational samples provided by applicants. They are subject to inspections by both the applicant and the regulatory authority. Other key responsibilities are listed as follows:

More Reasonable Time Requirements

The draft includes new and revised time requirements to make the procedure of clinical trial more reasonable. Key additions and revisions are:

• Retained investigational samples in clinical trials should be stored at least until the end of the shelf life of the samples.

• All paper and electronic records of clinical trials should be stored for at least 5 years after completion of the clinical trial.

• The observation period for investigational samples is proposed to be revised from a minimum of 7 days to "a length reasonably set according to the research's purpose and the biological characteristics of the main laboratory indices to be evaluated". Besides, the observation period should meet statistical requirements.

Enhanced Protocol Contents

The draft refines the contents of clinical trial protocol, which generally includes the basic information, research background, trial objectives, trial design, implementation methods, etc. The proposed revisions include:

• Investigators should complete registration and filing of clinical trials. This is in accordance with the Measures for Ethics Review of Biomedical Research Involving Humans issued by China in early 2023.

• The draft provides detailed requirements for research background, which should include product development review, target population and rationale, references and data source, investigational sample introductions and more.

• The draft removes the requirement of at least 100 subjects per trial group. Instead, the sample size should be determined through appropriate statistical methods based on the primary endpoints, and reasonable rationale should be provided, including data from previous studies and/or literature.

More Detailed Final Report Contents

The draft refines the contents of final reports, which comprise the front page, abstract, introduction, main text and appendices. Notably, the appendices should include:

• approval document from the Ethics Committee,

• clinical trial protocol,

• sample of informed consent form,

• case report forms,

• list of investigators, researchers, monitors, data managers and statistical analysts,

• investigational sample inspection reports and label instructions,

• major references for the clinical trial,

• and more.

Refined Definitions

• The scope of control sample is broadened. The draft defines control sample as other products used in clinical trials for clinical efficacy reference comparison with the investigational samples. The current standard states that control samples should be approved FSMP products of the same category with the investigational samples. If there are no such products, approved nutritionally complete foods or corresponding enteral nutritional formulations can be used.

• In the definitions of "Ethics Committee" and "monitor", "nutritional science" is added to the background scope of the personnel.

For consultation or translation services, please contact us.