To standardize the clinical trial process of foods for special medical purposes (FSMP), the State Administration for Market Regulation (SAMR) recently revised and issued the Quality Management Specifications for Clinical Trials of Foods for Special Medical Purposes (the Specification), which aims to ensure the scientific integrity, authenticity, and reliability of data and results, while safeguarding the safety and rights of trial subjects and consumers.
The Specification has been streamlined from 11 chapters and 54 articles to 8 chapters and 55 articles. It retains crucial sections such as general principles, responsibilities, clinical trial protocols, data management, statistical analysis, clinical trial reports, and appendices. Additionally, it introduces new chapters focusing on the implementation of clinical trials and clarifying terminology and definitions.
Moreover, the Specification has refined the requirements for clinical trial protocol design, strengthened focus on protecting the rights and interests of trial subjects, and underscored the practical application of FSMP in clinical settings.
SAMR encourages enterprises to innovate and develop new products addressing critical clinical nutrition needs, and it mandates that enterprises assume food safety responsibilities from the outset of the R&D stage. Furthermore, it urges strict adherence to the Specification requirements in conducting clinical trials of FSMP to ensure their quality, safety, and clinical efficacy, thus better meeting the nutritional requirements of patients.
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