China Formula food for special medical purposes (FSMP) will have new registration regulations in place as of January 1, 2024. The State Administration for Market Regulation (SAMR) has updated the previously published regulations (March 7, 2016) in line with the “four strictest requirements” for food safety emphasized by General Secretary Xi Jinping and the decisions outlined in the 20th Party Congress report regarding food and drug safety regulation.
Below you will find a summary and an interpretation of the key points:
The original Formula Food for Special Medical Purposes registration regulations have been in effect since July 1, 2016, and have played a crucial role in regulating product development, ensuring product quality and safety, and promoting industry growth. However, recent experiences with registration management highlighted the need for further enhancements. These revisions aim to tighten registration requirements, optimize the registration process, reinforce corporate responsibility throughout the product lifecycle, and improve the overall business environment to promote high-quality industry development.
Key Revisions in the Regulations
The revised regulations reflect feedback from stakeholders, emphasize a citizen-centric regulatory approach, and balance the “four strictest” food safety principles with industry development requirements. Some key revisions include:
- Prioritizing the review and approval of formula foods for special medical purposes for rare diseases and clinically urgently needed new types of formula.
- Defining seven circumstances in which registration will be denied.
- Enhancing labeling and instruction requirements, including explicit warnings and prohibitions.
- Streamlining on-site inspection procedures and timelines.
- Clarifying the legal validity of electronic certificates.
Denial of Registration
The revised regulations clearly state 7situations in which registration will be denied:
- The application materials are fraudulent or untrue;
- The application materials do not support the product safety, nutritional adequacy, and clinical effects for special medical purposes;
- The applicant does not have the R&D capacity, production capacity or inspection capacity suitable for the product applied for registration;
- The applicant fails to submit the supplementary and corrective materials within the prescribed time limit, or the supplementary and corrective materials submitted do not meet the requirements;
- Failing to confirm the date of on-site verification within the time limit, refusing or not cooperating with on-site verification or sampling inspection;
- The conclusion of the on-site verification report or the conclusion of the sample inspection report does not meet the registration requirements;
- Other circumstances that do not meet the registration requirements of laws, regulations, rules, national food safety standards and technical requirements.
The regulations reinforce the responsibilities and obligations of applicants, emphasizing their responsibility for the authenticity, completeness, legality, and traceability of submitted materials. Applicants must also cooperate with the SAMR during on-site inspections and provide necessary conditions for the registration process.
On-site Inspections and Sampling
The revised regulations detail the content of on-site inspections and sample testing, which may extend to food raw material and food additive manufacturers, if necessary.
To ensure product quality and safety, strengthen registration technical evaluation, and clearly add product technical requirements in the attachment 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 dynamically selected samples for on-site verification must be inspected in accordance with national food safety standards and product technical requirements.
Changes in Registration
If varieties of food raw materials and food additives remain unchanged, the order of the ingredient list remains unchanged, the nutritional composition list remains unchanged, and the usage amount fluctuates or adjusts reasonably within a certain range, there is no need to apply for change registration.
Please note that the prerequisite is that the “order of ingredients list” is unchanged.
Renewal of Registration
Applicants seeking registration renewal must submit documentation on research and development, production capabilities, inspection capabilities, product safety, nutrition adequacy, and clinical effects. Provincial-level food safety supervision and management departments are required to provide opinions on registration renewal.
Ethical committee approval is mandatory for clinical trials of specific full-nutrient formula foods. Samples used in clinical trials must adhere to Good Manufacturing Practices and comply with relevant food safety standards.
Labeling and Instruction Requirements
The regulations impose stricter labeling and instruction requirements, including clear and detailed product information, usage instructions, and warnings to guide consumers. Specifically:
- labels must indicate the name of formula food which must use the classification name or equivalent name specified in the national food safety standards and which also reflects the true attributes of the food
- in addition to the product name, labels must indicate the registration number, applicable population, and prominently display the text “please use under the guidance of a doctor or clinical dietitian”
- the label and instructions of formula food for special medical purposes shall describe the formula characteristics or nutritional characteristics of the product, and indicate “not suitable for use by non-target populations” and “this product is prohibited for parenteral nutrition support and intravenous injection” in accordance with the provisions of the national food safety standards
- labels and instructions shall not:
- contain false content
- involve disease prevention and treatment functions
- make functional claims about nutrients and other ingredients in the product
- mislead consumers.
- the contents of the label and instructions of formula food for special medical purposes shall be consistent, and their contents must be consistent with the content of the registration certificate
- if the label already contains all the contents of the instructions, a specific instructions manual does not need to be attached.
Penalties for Violations
The regulations enhance penalties for violations that cause harm, including fines up to 200,000 RMB for fraudulent acquisition of registration certificates and more. Minor violations may receive warnings and deadlines for correction.
The other main revisions in the new version of the registration regulations include:
- Clarification on the responsibilities of food approval agencies
- Clarification of the legal status and responsibilities of relevant personnel
- Clarification on the circumstances of application withdrawals. After the product is accepted, the withdrawal application can be made during the review process; if it is discovered during the technical review, on-site inspection, and sampling inspection that there is suspected illegal behavior such as concealing the true situation or providing false information, the registration shall not be withdrawn.
The revised regulations will take effect on January 1, 2024, and will replace the previously issued regulations from March 7, 2016.
These revisions in the “Regulations on the Registration of Formula FSMP” demonstrate China’s commitment to strengthening food safety and regulatory oversight while facilitating industry growth. Regulatory affairs professionals will need to adapt to these changes and ensure compliance with the updated requirements to guarantee product quality and safety in the market.
Read the original announcement on China formula food for special medical purposes registration regulations.
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