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China,Food,FSMP,Special,Medical,Purpose

On December 1, 2023, the State Administration for Market Regulation (SAMR) released the revised Administrative Measures for Registration of Food for Special Medical Purposes (hereinafter referred to as the new regulations), consisting of 7 chapters and 64 articles, set to be implemented from January 1, 2024. CIRS Group has compared the new regulations with the current Administrative Measures for Registration of Food for Special Medical Purposes (hereinafter referred to as the current regulations) and summarized the following ten major changes for your understanding.

Establishing Prioritized Review and Approval Procedures to Encourage Research and Innovation

A new general principle, “Guided by clinical nutritional needs” and “encouraging innovation”, has been introduced into the Article 4 of the new regulations. Additionally, Articles 34, 35, 36, and 37 have been added, setting up a prioritized review and approval process specifically for food for special medical purposes (FSMP). This process aims to encourage enterprises to develop FSMP products for rare diseases and those urgently needed in clinical practice and not yet approved to meet clinical needs. The measures include shortening the review period from the normal sixty working days to thirty, prioritizing on-site inspections, and arranging sample testing, among others.

New regulations

Article 4 The Administrative Measures for Registration of Food for Special Medical Purposes, guided by clinical nutritional needs, follow the principles of being scientific, transparent, fair and just, and encourage innovation.

Article 34 The applicant may apply for the prioritized review and approval procedures for FSMP if one of the following conditions is met:

FSMP for rare diseases;
FSMP is urgently needed in clinical practice and is not yet approved;
Other conditions specified by SAMR for prioritized review and approval.

Article 35 The applicant shall communicate with the review agency before submitting a registration application. After confirmation, the applicant shall submit a request for prioritized review and approval at the same time as the registration application is filed. Upon review, if the application meets the conditions set forth in Article 34 and there are no objections following public notification, the review agency will include it in the prioritized process.

Article 36 The review period is thirty working days for FSMP included in the priority review and approval process. Upon confirmation, the applicant may submit additional technical materials. If on-site inspections or sample testing are required, these are to be arranged with priority.

Article 37 Should the registration application for FSMP included in the prioritized process be found to fail to meet the conditions during the review process, the review agency is mandated to terminate the prioritized process for that product. Subsequently, the product will be reviewed under normal review procedures, and the applicant will be informed.

Current regulations

Article 4 The Administrative Measures for Registration of Food for Special Medical Purposes shall follow the principles of being scientific, transparent, fair, and just.

Article 16 The evaluation agency shall, based on the inspection report, test report and expert opinions, complete the technical review and reach the review conclusions within 60 working days upon receiving the accepted dossiers.

Further Emphasizing the Applicant’s Principal Responsibilities

New Regulations introduce new provisions that emphasize the conditions, capabilities, legal responsibilities, and obligations that the applicant shall possess, thereby further solidifying the responsibilities.

New regulations

Article 6 The applicant for Food for Special Medical Purpose Registration (hereinafter referred to as the applicant) shall be held accountable for the authenticity, integrity, legality and traceability of the materials submitted, and shall bear legal responsibilities.

The applicant shall cooperate with the market supervision and management department in conducting on-site inspections, sampling inspections, and other registration-related activities, providing necessary working conditions.

Current regulations

More Stringent Registration Requirements with a More Detailed Application Materials Catalog

The application materials catalog has been expanded from eight sections to ten; the current regulations of “2) Product R&D report, product formula design and its basis” has been divided into two separate sections in the new regulations as “3) Product R&D report” and “4) Product formula and the design basis”. Additionally, a new section, “2) Entity qualification documents of the applicant” has been added;
The current provision of “Product standards requirements” has been adjusted to “6) Product standards and technical requirements”, with technical requirements being added;
The current regulation of “For the registration of specific full-nutrient formula foods, clinical trial reports are required to be submitted” has been revised to “For the registration of specific full-nutrient formula foods, clinical trial reports are generally required to be submitted.”.

CIRS opinion: From the perspective of administrative measures, the newly added qualifier “generally” leaves room for the subsequent research and classification management of FSMP registration by SAMR.

New regulations

Article 8 The applicant shall submit the following materials to SAMR for FSMP registration:

1) Registration application;

2) Entity qualification documents of the applicant;

3) Product R&D report;

4) Product formula and the design basis;

5) Production process materials;

6) Product standards and technical requirements;

7) Drafts of product labels and instructions;

8) Product test reports;

9) Materials on R&D, production and testing capabilities;

10) Other materials demonstrating the safety, nutritional adequacy, and clinical effectiveness for special medical purposes.

For the registration of specific full-nutrient formula foods, clinical trial reports are generally required to be submitted.

Current regulations

Article 9 The applicant shall submit the following materials to SAMR for FSMP registration:

1) Registration application;

2) Product R&D report, product formula design, and its basis;

3) Production process materials;

4) Product standards requirements;

5) Drafts of product labels and instructions;

6) Test reports of the test samples;

7) Materials demonstrating the R&D, production and testing capabilities;

8) Other materials demonstrating the safety, nutritional adequacy, and clinical effectiveness for special medical purposes.

For the registration of specific full-nutrient formula foods, clinical trial reports are required to be submitted.

More Stringent Registration Requirements: Production On-Site Extended Inspection Added

It is added in the new regulations that “When necessary, extended inspections may be conducted on food raw materials and food additives manufacturers.”.

New regulations	Article 14: The review agency shall conduct production site inspections and sampling inspections based on food safety risks, as well as on-site inspections of clinical trials. When necessary, extended inspections may be conducted on food raw materials and food additives manufacturers.
Current regulations	Article 11 The review agency shall review the dossiers submitted, conduct on-site inspections of the applicant according to actual needs, carry out sampling inspections on test samples, on-site inspections of clinical trials and expert evaluations regarding specific issues.

Shortening the Time Frame for Clinical Trial Inspection to Improve Review Efficiency

The new regulations streamline the on-site inspection process, reducing the time required for the on-site verification of clinical trials from the current “within 40 working days” to “within thirty working days”.

New regulations	Article 18 For on-site inspection of clinical trials for the registration of specific full-nutrient formula foods, the review agency shall complete the inspection of the authenticity, completeness, legality, and traceability of the clinical trials within thirty working days from the date confirmed by the applicant to carry out the inspection, and issue an inspection report.
Current regulations	Article 14 The inspection agency shall complete the inspection of the authenticity, completeness, and accuracy of the clinical trials within forty working days from the date of receiving the notification from the review agency, and issue an inspection report.

Explicitly Identifying 7 Situations Where Registration is Not Granted

It is stipulated in Article 21 of the new regulations that the review agency is mandated to issue a preliminary decision of non-approval of registration if any of the following situations occur:

1) Falsification or untruthfulness in the application dossiers;

2) Lack of support in the application dossiers regarding the safety, nutritional adequacy, and clinical effectiveness of the product;

(3) The applicant lacks the research and development, production, or testing capabilities suitable for the registered product;

(4) Failure to submit correction dossiers within the specified time limit or the submitted dossiers do not meet the requirements;

(5) Inability to confirm the on-site inspection date within the prescribed time limit, refusal, or failure to cooperate with on-site inspection and sampling inspection;

(6) On-site inspection or sampling inspection report conclusion indicating non-compliance with the registration requirements;

7) Any other situations that do not comply with the registration requirements specified in relevant laws, regulations, rules, national food safety standards, and technical requirements.

Standardizing Labeling and Clarifying the Placement of Warning Statements

The placement of the advisory statement “Please use under the guidance of a doctor or clinical nutritionist” is adjusted from the current requirement of “in a noticeable position” to the “main display surface”, aligning with the provisions outlined in the SAMR Announcement No. 42 of 2022, Guidelines for Labeling of Special Medical Purpose Formula Foods issued on December 28, 2022.

New regulations	Article 46 The product name, registration number, target population, and the advisory statement that “Please use under the guidance of a doctor or clinical nutritionist.” shall be indicated on the main display surface of the labels for food for special medical purposes.
Current regulations	Article 38 Labels and instructions of food for special medical purposes shall, in accordance with national food safety standards, bear a statement in a noticeable position that: (1) Please use under the guidance of a doctor or clinical nutritionist.

Standardizing Labeling and Adding Prohibitive Requirements for Function Claims

The newly added provision “they must not make functional claims about the nutrients and other components in the product, or mislead consumers” is consistent with the requirements specified in SAMR Announcement No. 42 of 2022, Guidelines for Labeling of Special Medical Purpose Formula Foods issued on December 28, 2022.

New regulations

Article 48 The applicant is responsible for the content provided on the labels and instructions of the food for special medical purposes. Labels and instructions shall be truthful, accurate, clear, and easy to identify. They must not contain any false information, nor should they relate to disease prevention or treatment functions. In addition, they must not make functional claims about the nutrients and other components in the product, or mislead consumers.

Current regulations

Article 35 Labels and instructions of food for special medical purposes shall be accurate, clear, durable, easy to identify and read.

Article 36 Labels and instructions of food for special medical purposes shall not contain any false information, nor should they relate to disease prevention or treatment functions. The manufacturers are held accountable for the content provided on the labels and instructions.

Expanding the Current Regulations to Include “Other Technical Requirements for the Product”

(1) The applicant shall submit the “Product standards and technical requirements” to SAMR when applying for the registration of food for special medical purposes. Compared to the current regulations, the “technical requirements” have been added;

(2) In addition to complying with the national food safety standards, enterprises shall also organize production and batch inspection according to the product’s technical requirements;

(3) For samples dynamically drawn during on-site inspection, the inspection agency will conduct inspection according to the national food safety standards and the product’s technical requirements;

(4) The Annex to the approved registration certificate will specify items related to “(8) Other technical requirements for the product”.

CIRS opinion

“Other technical requirements for the product” mainly refer to characteristic indicators related to the clinical efficacy of a category of food for special medical purposes, which are not covered or explicitly stipulated in the current general standards. By including product technical requirements in the current regulations, the quality, safety, and effectiveness of the products can be further ensured.

New regulations

Article 7 The applicant shall [...], conduct batch inspections on the finished products in accordance with relevant laws and regulations, national food safety standards, and technical requirements.

Article 17 The inspection agency shall, in accordance with the national food safety standards and technical requirements, complete the sample inspection within thirty working days upon receiving the samples, and issue a sample inspection report to the review agency.

Article 25 The registration certificate of food for special medical purposes and its Annex shall specify the following items:

Product name;
Name of the enterprise and the production address;
Registration number, date of approval, and validity period;
Product category;
Product formula;
Production process;
Samples of the product label and instructions; and
Other technical requirements for the product.

Current regulations

Article 8 The applicant shall [...], have the capability to conduct batch inspections for all items as stipulated in the national standards for food for special medical purposes.

Article 13 The inspection agency shall complete the sampling inspection within 30 working days from the date of acceptance of the commission.

Article 20 The registration certificate of food for special medical purposes and its Annex shall specify the following items:

Product name;
Name of the enterprise and the production address;
Registration number and validity period;
Product category;
Product formula;
Production process; and
Product label and instructions.

Strengthening and Increasing the Intensity of Handling Violations

For applicants who obtain registration certificates through deception, bribery, or other improper means that result in harmful consequences, and for those who forge, alter, resell, rent, lend, or transfer registration certificates resulting in harmful consequences, the maximum fine is adjusted to 200,000 RMB. It is also clarified that if a crime is suspected, the matter should be transferred to the public security organs according to the law to pursue criminal responsibility.

New regulations

Article 58 If an applicant obtains the registration certificate of food for special medical purposes through deception, bribery, or other improper means, the State Administration for Market Regulation shall revoke the certificate according to the law. The permit holder shall not be allowed to apply for registration of FSMP again within three years; a fine of not less than 10,000 RMB but not more than 30,000 RMB shall be imposed; if harm is caused, a fine of not less than 30,000 RMB but not more than 200,000 RMB shall be imposed; if a crime is suspected, the case shall be transferred to the public security organs according to the law to pursue criminal responsibility.

Current regulations

Article 44 If the permit holder obtains the registration certificate through deception, bribery, or other improper means, the National Food and Drug Administration shall revoke the registration certificate and impose a fine of not less than 10,000 RMB but not more than 30,000 RMB; the applicant shall not be allowed to apply for registration again within three years.

Summary

The new regulations are set to be officially implemented on January 1, 2024. It is speculated by CIRS Group that, to ensure the smooth implementation of the new registration regulations, SAMR should revise the supporting documents.

In comparison with the current regulations, the basic framework concerning application and registration, clinical trials, labeling and instructions, supervision and management, as well as legal liabilities remains unchanged. The most significant changes in the new regulations pertain to a stricter set of requirements in several aspects, including the principal responsibility of the applicant, dossier submission, on-site inspection, and labeling. We advise that enterprises that are preparing to apply for FSMP closely monitor updates to the corresponding supporting documents and prepare in advance.

If you need any assistance or have any questions, please get in touch with us via service@jianzaoshiwang.cn.

For more information

SAMR News

A Comprehensive Review of the Registration and Approval Status of Foods for Special Medical Purpose (FSMP) in 2023

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SAMR Issued Revised Administrative Measures for Registration of Food for Special Medical Purposes: Summary of the Ten Major Changes

Establishing Prioritized Review and Approval Procedures to Encourage Research and Innovation

Further Emphasizing the Applicant’s Principal Responsibilities

More Stringent Registration Requirements with a More Detailed Application Materials Catalog

More Stringent Registration Requirements: Production On-Site Extended Inspection Added

Shortening the Time Frame for Clinical Trial Inspection to Improve Review Efficiency

Explicitly Identifying 7 Situations Where Registration is Not Granted

Standardizing Labeling and Clarifying the Placement of Warning Statements

Standardizing Labeling and Adding Prohibitive Requirements for Function Claims

Expanding the Current Regulations to Include “Other Technical Requirements for the Product”

Strengthening and Increasing the Intensity of Handling Violations

Summary