On October 18, 2021, the State Administration of Market Regulation (SAMR) drafted revisions to the "Administrative Measures for the Registration of Formula Foods for Special Medical Purposes"(Draft for Comments)". The Article 20 of the draft clarifies 9 situations in which registration is not granted. Foodmate summarized these situation for your reference.

(1) The application materials are falsified and untrue;

(2) The application materials do not support product safety, nutritional adequacy, and clinical effects for special medical purposes;

(3) The applicant does not have the R&D, production or inspection capabilities that are compatible with the product being applied for registration;

(4) The applicant fails to submit supplementary materials within the prescribed time limit or the supplementary materials provided do not meet the requirements;

(5) The applicant fails to confirm the on-site inspection within the time limit, refuses or fails to cooperate with the on-site inspection or sampling inspection;

(6) The conclusion of the verification report or the conclusion of the inspection report does not meet the registration requirements;

(7) There is no obvious difference between the product applied for registration by the same applicant and the product formula of the same type that has applied for registration;

(8) The same applicant uses the same formula to apply for registration of products with different names;

(9) Other situations that do not meet the registration requirements of the Food Safety Law, National Food Safety Standards and technical requirements.