China formula food for special medical purposes

Friday, 14 June 2024 / Published in Health Food, News, NMPA Registration in China

China Food for Special Medical Purposes – Clinical Trial Standards update

China Formula Food for Special Medical Purposes (FSMP) Clinical Trial Standards were updated and issued by the State Administration for Market Regulation (SAMR) on May 11, 2024. These guidelines, which came into effect immediately, replace the provisional standards issued in 2016 by the former China Food and Drug Administration.

The primary objective of these guidelines is to standardize the clinical trial process for FSMP, ensuring the scientific integrity, authenticity, and reliability of trial data and results, while protecting the safety and rights of trial participants. The guidelines cover the entire clinical trial process, including design, execution, data management and analysis, and the clinical trial summary and reporting. Below we highlight the main elements as well as a FAQ section for better comprehension of the differences between the previous provisional version and this new current version:

Medical institutions conducting these trials must:

have relevant clinical nutrition departments and professional capabilities,
be registered in the SAMR’s special food verification and evaluation technical institution information system.

Clinical Trial Protocols must:

include basic information, research background, objectives, design, management.
take into account the characteristics of the product formula, nutritional characteristics, target audience, etc.,
pay attention to the actual clinical application effect of the product
explain the scientific and rational basis of the experimental design.
determine the sample size and trial period based on different disease types and trial designs, all the while meeting statistical requirements.

Implementation:

Applicants must create risk management plans and implement quality control measures.
Trials should be conducted using products that match the registered formulation, manufacturing process, product standard and technical requirements.
Applicants, researchers, etc., need to ensure participants understand the trial process, risks, benefits, and give informed consent.

Reporting:

Clinical trial reports must include detailed descriptions of the trial design, process, safety, nutritional adequacy, clinical effects, and a conclusion.
Reports should analyze all adverse events and provide a comprehensive risk-benefit assessment of the product.

Frequently Asked Questions and Answers

1. What adjustments have been made to the overall framework of the guidelines?

Answers:

The chapters have been reorganized in the new guidelines according to the sequence of clinical trial conduct, focusing on quality management throughout the entire process. The content from the 2016 version related to clinical trial implementation conditions, participant rights protection, and trial product management has now been integrated into sections on responsibilities and trial implementation. This restructuring aims to facilitate operational execution and clearly define the specific responsibilities of all parties involved.

2. What is included in the sample management for FSMP clinical trials?

Answers:

The Ethics Committee must review the trial samples inspection reports issued by legally certified food testing institutions.
Applicants must establish quality management procedures for trial samples, ensuring their stability during the clinical trial as well as being responsible for their quality and trial safety. Retained samples should be kept until their expiration date at least.
Clinical trial institutions and researchers are responsible for managing the trial samples provided by the sponsor. Researchers must ensure that trial samples are used according to the clinical trial protocol and they must explain the usage methods to participants. Trial samples cannot be repurposed, sold, or indirectly sold.

3. What adjustments have been made to the clinical trial protocol design requirements?

Answers:

No specific numerical requirements for the number of participants and trial duration are provided. Instead, the sample size and trial period should be determined based on the type of disease and trial design, while meeting statistical requirements.
Examples of clinical trial observation indicators, such as safety, have been removed. These indicators should now be set based on the product characteristics and target population or they can refer to clinical trial technical guidelines for the relevant product category.