7. What contents are specified in the registered changes?

For registered changes, a product change demonstration report must be submitted, which specifies that the types of food raw materials and additives remain unchanged, the order of ingredients in the recipe remains the same, and the nutritional composition table remains the same. If the amount of use is reasonable within a certain range or adjusted, it is not necessary to apply for registered changes.

8. What adjustments are required for registered renewal?

For registered renewal, materials such as enterprise research and development capabilities, production capabilities, inspection capabilities, product safety, nutrition adequacy, and special clinical effects tracking evaluations are required to be submitted. The provincial-level food safety supervision and management department is required to issue a renewal registration opinion. If the applicant fails to maintain research and development capabilities, production capabilities, and inspection capabilities, the registration will not be renewed.

9. What contents are specified in clinical trials?

To conduct specific full-nutrient formula food clinical trials, it must be approved by the ethics committee; the trial samples used should be produced by the applicant according to the registered product formula and production process. The production conditions should comply with the Good Manufacturing Practice for special medical food, and the product should comply with the corresponding national food safety standards and technical requirements.

10. What requirements are there for labels and instructions?

The "Measures" further stricts the requirements of label and instruction marking, specifying the main display content of the label. It requires describing the product's formula characteristics or nutritional features to reflect the properties of special medical food products. It also prompts consumers to use the product under the guidance of a doctor or clinical nutritionist, and provides warning language to guide consumers on its appropriate use. It is specified that no functional claims may be made for nutrients and other ingredients in the product to avoid misleading consumers.

11. What adjustments does the "Measures" make to the content on illegal disposal?

In accordance with the principle of leniency, severity, and proportionality of the Administrative Penalty Law of the People's Republic of China, the punishment for harmful behavior caused by the applicant obtaining the registration certificate through deception, bribery, or similar means is increased. The maximum fine is adjusted to 200,000 yuan for those who commit crimes of forgery, alteration, resale, rental, and transfer of registration certificates resulting in harmful consequences. If there is suspicion of a crime, it will be transferred to the public security organs for criminal responsibility. At the same time, the punishment for minor violations is reduced, and it is stipulated that applicants who fail to apply for changes in matters that do not affect product safety, nutrition adequacy, and special medical use clinical effects shall be notified to correct within a time limit and will be fined if they fail to do so.

12. In what areas has the "Measures" been revised?

The "Measures" have been mainly revised in the following three aspects: First, the responsibilities of the food evaluation agency have been clarified. The food evaluation center of the State Administration for Market Regulation is responsible for the acceptance, technical review, on-site verification, certificate production, and delivery of special medical food registration applications, and organizes experts as needed to conduct demonstrations. Second, the legal status and responsibilities of relevant personnel have been clarified. Institutions and personnel involved in technical review, on-site verification, sample inspection, and expert demonstrations should be responsible for the registration opinions, review conclusions, on-site verification reports, sample inspection reports, and expert opinions issued, and abide by professional ethics. Third, conditions for withdrawing the application have been clarified. After the product is accepted, the application may be withdrawn during the review process. If illegal acts such as concealing the truth or providing false information are found during technical review, on-site verification, and sample inspection, the registration application cannot be withdrawn.

13. When will the "Measures" come into effect?

The "Measures" will come into effect on January 1, 2024, and the "Management Measures for the Registration of Special Medical Use Formula Foods" issued by the former State Food and Drug Administration on March 7, 2016, will be simultaneously abolished.