CHINA FOOD AND DRUG ADMINISTRATION SOLICITS OPINIONS ON THE GUIDELINES FOR TWO CLINICAL TRIALS OF FORMULA FOODS FOR SPECIAL MEDICAL PURPOSES

—Formula food for kidney diseases & muscular attenuation syndrome

In order to further standardize the clinical trial work of formula foods for special medical purposes, to make the clinical research results more scientific and reliable, China Food and Drug Administration (CFDA) issued a draft of the “Guidance for clinical trials of formula foods for special medical purposes for kidney diseases (exposure draft)” and the “Guidance for clinical trials of formula foods for special medical purposes for muscular attenuation syndrome (exposure draft)” in accordance with the “Food Safety Law of the People’s Republic of China”, “Measures for the administration of registration of formula foods for special medical purposes” and “Quality management practices of formula foods for special medical purposes (trial)”. Public opinions from related companies can be submitted to CFDA before February 9, 2018.

Guidance for clinical trial of formula foods for special medical purposes for kidney diseases is a general principle for reference that needs to be considered in clinical trial research of total nutrition formula foods for kidney disease. The main contents include the test purpose, subject selection, withdrawal and termination criteria, test sample requirements, test program design, observation indicators, result judgment, data statistics and management, etc. of clinical trial, to provide guidance for the design, implementation and evaluation of the clinical trial of full nutrition formula for kidney diseases.

Guidance for clinical trials of formula foods for special medical purposes for muscular attenuation syndrome is general principle for reference that needs to be considered in clinical trial research of total nutrition formula foods for muscular attenuation syndrome. The main contents include the test purpose, subject selection, withdrawal, elimination and termination standards, test sample requirements, test program design, observation indicators, result judgment, data statistics and management, etc. of clinical trial, to provide guidance for the design, implementation and evaluation of the clinical trial of full nutrition formula for muscular attenuation syndrome.

For more information refer to formula foods for special medical purposes please also see: https://www.linkedin.com/pulse/china-food-drug-administration-issued-registration-list-rong-liu/