China Unveils the Key Points and Determination Principle of Clinical Trial On-Site Inspection for FSMP Registration

On November 11, 2024, China State Administration for Market Regulation released the Key Points and Determination Principle of Clinical Trial On-Site Inspection for Food for Special Medical Purposes (FSMP) Registration, applicable to the registration of complete nutrition formula food, which is a type of FSMP. This document specifies the examination details of on-site inspection for FSMP clinical trial and situations where the inspection will be failed. It has been effective since the date of promulgation.

As per the document, the key points of clinical trial on-site inspection involve:

1. Condition and compliance for clinical trial

2. Ethical review

3. Informed consent

4. Participant screening

5. Clinical trial scheme implementation

6. Security information processing and reporting

7. Clinical trial records

8. Clinical trial data tracing

9. Clinical trial sample management

10. Biological sample management

Each perspective contains multiple items, with specific inspection criteria established for each item. For instance, Ethics Committee approval is one of the key requirements for “Condition and compliance for clinical trial”. During inspection, the regulatory authority will verify the ethics review approval documentation, ensuring that the approval date precedes both the informed consent date and the screening date of the first participant.

In case any of the following situations occurs, the inspection will be failed:

1. Fabricating or modifying clinical trial data without reasonable explanation, including subject information, main trial process records, research data, and test data;

2. Concealing or discarding trial data without reasonable explanation, or selectively using trial data in other ways that violate the trial protocol;

3. Failing to report serious adverse events and their severity;

4. Concealing or using concurrent medications or nutritional preparations prohibited by the trial protocol without reasonable explanation;

5. Using counterfeit trial samples;

6. Cases where main clinical trial data cannot be traced or have serious reliability issues;

7. Cases where application materials are inconsistent with the original records and affect result evaluation;

8. For problems discovered during inspection, after comprehensive review, those deemed to have serious impact on subject rights, product safety, nutritional adequacy, and/or the clinical effects evaluation of the special medical purpose;

9. Other circumstances that shall not pass approval as stipulated by laws and regulations.