Recently, the State Administration for Market Regulation revised and issued the Administrative Measures for the Registration of Formula Food for Special Medical Purposes (hereinafter referred to as the "Measures"), which will come into force on January 1, 2024.
Formula food for special medical purposes (hereinafter referred to as special medical food) refers to formula food specially processed and formulated to meet the special needs of nutrients or diet for people with restricted feeding, digestive and absorption disorders, metabolic disorders or specific disease states. Special medical food plays an important role in nutritional support for patients' diseases and maintenance of body functions, and its quality and safety are related to the health and life safety of special populations.
The Measures implement the "four strictest" requirements of food safety, combine industry development and registration management practices, further tighten product registration conditions, requirements and procedures, ensure product quality safety and clinical effects, emphasize clinical demand-oriented, encourage enterprises to develop clinically urgently needed products, and continuously expand the accessibility of special populations. The Measures consist of 7 chapters and 64 articles, which stipulate the application conditions, registration procedures, clinical trials, labeling and instructions, supervision and management, and legal liability of overseas manufacturers that intend to produce and sell special medical food in China and export special medical food to ChinaThe first is to strictly register products and refine management requirements. Further emphasis is placed on the qualifications, abilities, legal responsibilities and obligations that applicants should have;Clarify 7 types of non-registered products;Refine on-site verification requirements, and carry out extended verification of raw materials if necessary;The item of "other technical requirements for products" is added to the registration certificate to further ensure the safety and effectiveness of product quality.
The second is to encourage R&D and innovation to meet clinical needs. Establish a priority review and approval procedure to implement priority review for products with rare disease categories, products that are urgently needed for clinical use and have not yet been approved, shorten the review time limit from a maximum of 90 working days to 30 working days, give priority to on-site verification and sampling inspections, and encourage enterprises to develop new products to meet clinical needs.
The third is to standardize labeling and identify and safeguard the rights and interests of consumers. It is emphasized that the label of special medical food should be true, accurate, clear and obvious, and meet the requirements of regulations and standardsStrict labels mainly display the content that should be marked on the layout to facilitate consumer identification;It is clarified that product labels shall not make functional claims about nutrients and other ingredients in products, so as to prevent misleading consumers.
Fourth, optimize the registration process and improve the efficiency of registration. Optimize the registration on-site verification process, give the enterprise 30 working days to feedback whether to accept the on-site inspection, and clarify the specific verification time, taking into account the verification preparation and work timelinessShorten the time limit for on-site verification of clinical trials by 10 working days to improve the efficiency of product registrationClarify the legal effect of electronic certificates and facilitate service enterprises.
Fifth, it is necessary to strictly supervise and manage and strengthen legal responsibility. Applicants suspected of concealing the true situation or providing false information during the registration process shall expressly not withdraw the registration application and shall be dealt with in accordance with the law. Increase the extent of punishment for violations of laws and regulations such as obtaining registration certificates by fraud and bribery, as well as forgery, alteration, reselling, leasing, lending, or transferring registration certificates. and where a crime is suspected, it shall be transferred to the public security organs in accordance with law and criminal responsibility shall be pursued.
Interpretation of the Measures
In order to thoroughly implement the "four strictest" requirements of the general secretary on food safety and the decision-making and deployment of the "food and drug safety supervision" in the report of the 20th National Congress of the Communist Party of China, further improve the registration management of formula food for special medical purposes (hereinafter referred to as special medical food), and ensure product quality and safety, the State Administration for Market Regulation revised and issued the "Administrative Measures for the Registration of Formula Food for Special Medical Purposes" (hereinafter referred to as the "Measures"). The relevant content is interpreted as follows.
1. What is the background of the revision of the Measures?
Since its implementation on July 1, 2016, the Measures have played an important role in standardizing product R&D registration, ensuring product quality and safety, promoting the steady development of the industry, and safeguarding the health rights and interests of people with special disease conditions. However, judging from the registration management practice in recent years, there is still room for improvement in the current regulations, and it is necessary to further tighten the registration requirements for special medical foods, optimize the registration management process, consolidate the main responsibilities of enterprises in the whole process, continue to optimize the business environment, and promote the high-quality development of the industry.
2. What are the main revisions of the Measures?
Combined with the practice of registration management in recent years, the Measures extensively listen to the opinions and suggestions of relevant parties, practice the concept of supervision for the people, and take into account the "four strictest" food safety and service industry development requirements. In terms of regulation for the people, it is emphasized that the registration of special medical food is guided by clinical nutritional needsFormulate priority review and approval procedures, include rare diseases and new types of special medical foods that are urgently needed for clinical treatment into the priority review and approval procedures, and guide and encourage enterprises to develop products that are urgently needed for clinical purposes to meet the needs of clinical patients. In terms of strict registration requirements, it emphasizes the conditions and abilities that applicants should have, as well as the legal responsibilities and obligations they should bearClarify the circumstances under which 7 products will not be registered;The item of "other technical requirements for products" is added to the registration certificate to further ensure the safety and effectiveness of product quality. Highlight the characteristics and prohibitive requirements of labels and instructions;Intensify the handling of violations. In terms of optimizing the business environment, the on-site verification process was optimized and the on-site inspection content was refinedShorten the time limit for clinical trial verification and improve the timeliness of review and approvalclarify the legal validity of electronic certificates, etc.
3. What are the circumstances under which registration is not allowed?
The original "Measures" required that special medical food should meet the requirements of relevant laws and regulations and national food safety standards, and did not specify the circumstances under which it would not be registered. The revised "Measures" clarify seven situations in which registration may not be granted: first, the application materials are fraudulent and untrue;Second, the application materials do not support the product safety, nutritional adequacy and clinical effect for special medical purposes;Third, the applicant does not have the R&D ability, production capacity or inspection ability suitable for the product applied for registration;Fourth, the applicant fails to submit the supplementary materials within the prescribed time limit, or the supplementary materials submitted do not meet the requirements;Fifth, the on-site verification date cannot be confirmed within the time limit, and the on-site verification or sampling inspection is refused or not cooperatedSixth, the conclusion of the on-site verification report or the conclusion of the sample inspection report does not meet the registration requirements;Seventh, other situations that do not meet the registration requirements of laws, regulations, rules, national food safety standards and technical requirements.
4. What are the adjustments to the requirements for applicants?
The Measures further emphasize the conditions, abilities, legal responsibilities and obligations that applicants should have, and consolidate the main responsibilities of applicants. For example, the applicant shall be responsible for the authenticity, completeness, legitimacy and traceability of the submitted materials, and bear legal responsibilityThey shall cooperate with the market regulation departments to carry out on-site inspections, sampling inspections, and other work related to registration, and provide necessary working conditions.
5. What are the contents of on-site verification and sampling inspection?
The revised Measures clarify that the review agency shall conduct on-site verification and sampling inspection of the applicant and on-site inspection of clinical trials according to the food safety risk organization. If necessary, extended verification can be carried out on food raw materials and food additive production enterprises.
6. What are the contents of the registration certificate?
In order to ensure product quality and safety, strengthen the technical review of registration, and clearly add product technical requirements to the annex of the registration certificate. In addition to meeting the corresponding national food safety standards, enterprises should also organize production in accordance with the registered product technical requirements;The samples dynamically taken for on-site verification shall be inspected in accordance with the national food safety standards and product technical requirements.
7. What are the contents of the change of registration?
If the change registration needs to submit a product change demonstration report, it is clear that if the varieties of food raw materials and food additives remain unchanged, the order of the ingredient list remains unchanged, the nutritional content list remains unchanged, and the usage amount fluctuates or adjusts reasonably within a certain range, it is not necessary to apply for change of registration.
8. What are the adjustments to the renewal of registration?
To renew the registration, it is necessary to submit materials such as the company's R&D capabilities, production capacity, and inspection capabilities, as well as the follow-up evaluation of product safety, nutritional adequacy, and clinical effects of special medicineThe provincial food safety supervision and management department is required to issue an opinion on the renewal of registration. If the applicant fails to maintain R&D capabilities, production capacity, and inspection capabilities, the registration will not be renewed.
9. What are the contents of the clinical trial?
The clinical trial of specific whole nutrition formula food shall be reviewed and approved by the ethics committee;The test samples used for clinical trials shall be produced by the applicant in accordance with the product formula and production process applied for registration, the production conditions shall conform to the good manufacturing practices of special medical food, and the products shall meet the corresponding national food safety standards and technical requirements.
10. What are the adjustments to the requirements for labels and instructions?
The Measures further tighten the labeling requirements for labels and instructions, and clarify the content of the main display layout of the label;It is required to describe the formula characteristics or nutritional characteristics of the product to reflect the attributes of the special medical food productOn the label and instruction manual, consumers are reminded to "please use it under the guidance of a doctor or clinical dietitian" and warning words to guide consumers to use it correctlyIt is expressly forbidden to make functional claims about nutrients and other ingredients in products to avoid misleading consumers.
11. The "Measures" have a negative impact on the content of the dispositionWhat adjustments have been made?
In accordance with the principle of blending leniency and severity and proportionate punishment in the "Administrative Punishment Law of the People's Republic of China", increase the degree of punishment for acts that cause harmful consequences, and adjust the upper limit of fines for applicants who obtain registration certificates by fraud, bribery and other improper means to cause harmful consequences and forge, alter, resell, lease, lend, or transfer registration certificates to 200,000 yuan, and make it clear that if a crime is suspected, it will be transferred to the public security organ in accordance with law and investigated for criminal responsibility. At the same time, the punishment for minor violations has been reduced, stipulating that if the applicant changes the matters that do not affect the safety, nutritional adequacy and clinical effect of special medical purposes, and fails to apply for the change in accordance with the law, he will be ordered to make corrections within a time limit, and a fine will be imposed if he fails to make changes within the time limit.
12. In what other ways have the Measures been revised?
The Measures have also been revised mainly in the following three aspects: First, the responsibilities of the food evaluation agency are clarified, and the food evaluation agency (food evaluation center) of the State Administration for Market Regulation is responsible for the acceptance, technical review, on-site verification, and delivery of special medical food registration applications, and organizes experts to conduct demonstrations as needed. The second is to clarify the legal status and responsibilities of relevant personnel, and the institutions and personnel in technical review, on-site verification, sampling inspection, and expert demonstration shall be responsible for the acceptance opinions, review conclusions, on-site verification reports, sample inspection reports, and expert opinions issued, and abide by professional ethics. The third is to clarify the circumstances under which the application is withdrawn. After the product is accepted, an application for withdrawal can be submitted during the review process;If it is found that there are suspected illegal acts such as concealing the true situation or providing false information in the process of technical review, on-site verification and sampling inspection, the registration application shall not be withdrawn.
13. When will the Measures come into force?
The Measures shall come into force on January 1, 2024, and the Administrative Measures for the Registration of Formula Food for Special Medical Purposes promulgated by Order No. 24 of the former State Food and Drug Administration on March 7, 2016 shall be repealed at the same time.
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