SAMR Issuing Guideline on Clinical Trial of Diabetes, Nephropathy and Cancer

China,Food,CLINICAL Trial

On October 11, 2019, SAMR issued guideline on clinical trial of diabetes, nephropathy and cancer, and announced that they are implemented from the date of release. Since the Q&A of General Rules for Food for Special Medical Purposes (GB 29922) stipulates the adjusted range of nutrients for the products of the three diseases, from now on, therefore, the legal basis are complete, which means they are ready for R&D, produ ction and registration. While with the development of medical research and the improvement of the regulatory system, the further adjustment of nutrient indexes in the following standards are not excluded. For instance, the Q&A of GB 29922 requires for cancer specific nutritionally complete food that, the high-quality protein shall at least be 50% of the total protein, but the draft of Specific Nutritionally Complete Foods for Cancer suggested that it should be all high-quality protein, etc.

Please click here to know the official link for the details of the three guidelines.

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