On October 18, 2021, the SAMR issued the Measures for the Registration of Food for Special Medical Purpose (Draft for Comments) (hereinafter referred to as "Draft"), which further clarified and improved registration requirements and legal responsibilities. Antion analyzed and interpreted the main changes as follows:

1. Updated the institution name

The institution name responsible for the registration and management of food for special medical purpose was changed from "China Food and Drug Administration" to "State Administration for Market Regulation", which was consistent with the name of the government institution after reformation.

2. Adjusted the registration document items

The registration document items of the application for food for special medical purpose were adjusted from "8+1 (clinical trial report submitted when applying for the registration of special full nutritional formulas)" to "9+1 (clinical trial report submitted when applying for the registration of special full nutritional formulas)", "product research and development report, product formula design and its basis" were divided into "product research and development report" and "product formula design basis", it is expected to have stricter requirements on this item documents in the future. Product formula design basis should comply with the related regulations of Registration Application Document Items and Requirements of Food for Special Medical Purpose (Trial Implementation) 2017 Version and related Q&A requirements that were announced in 2021.

Among them, it should be noted that the document requirement for the registration application of the special full nutritional formulas has been modified from "clinical trial report should be submitted" to "clinical trial report should generally be submitted", whose semantic was more relaxed leaving room for special circumstance.

3. Clarified that the products applying for registration need to carry out on-site verification and sampling inspections

The Draft clarified that "conduct on-site verification and sampling inspections for applicants, and conduct on-site verification for clinical trials", and put forward higher demands, "extend inspections can be carried out on food raw materials and food additives manufacturers if necessary", which requires the cooperation of product raw material suppliers and shows strict inspection for products, reflecting the implementation of the "four strictest" requirements for food safety. The on-site verification link gives the applicant 30 working days to prepare, which is consistent with the requirements of the Regulations for On-site Verification Work of Special Food Registration (Interim) and is conducive to enterprises to adjust production plans, assign work contents, and make preparations in advance to facilitate the smooth progress of on-site inspections.

4. The requirements for changes and renewal of registration were more scientific and reasonable

The application documents of changes of registration supplemented the requirement of the "product change demonstration report" item, and at the same time made it clear that the actual production conditions allowed the use amount of food raw materials and food additives to fluctuate within a certain range. The renewal of registration has newly supplemented the requirement of the "production and sales of products within the validity period of the registration certificate verified by the provincial food safety supervision and administration department and the renewal of registration opinion" item, which will be more stringent on the application documents for change and renewal of registration.

5. Newly supplemented 9 situations of termination of review and denying registration

The Draft newly supplemented 9 situations of termination of review and denying registration: false or untrue application documents, which do not support product safety, nutritional adequacy, and clinical effects for special medical purposes; applicants do not have the research and development, production or inspection capabilities compatible with those required by the product applied for registration, the supplementary documents are not submitted within the specified time or do not meet the requirements, the on-site inspections cannot be confirmed after the specified time, and the on-site inspection or sampling inspection is rejected or not cooperated; the conclusion of the verification report or the inspection report is that the product does not meet the registration requirements; there is no obvious difference between the product applied for registration by the same applicant and the product formula of the same type of product that has already applied for registration; the same applicant uses the same formula to apply for the registration of products with different names.

6. Supplemented priority review and approval procedures

The Draft set up priority review and approval procedures, clarified that food for special medical purpose for rare disease and clinically urgently needed and unapproved new types of food for special medical purpose were applicable to priority review and approval procedures, and guided and encouraged enterprises to develop and register food for special medical purpose clinically urgently needed and for rare disease categories to meet clinical needs.

7. Clarified relevant legal responsibilities

The Draft further clarified the main responsibility of the applicant in the registration process. If a crime was suspected, it shall be transferred to the public security organs in accordance with the law, and criminal responsibility shall be investigated. In cases where the applicant conceals the truth or provides false documents to apply for registration, the registration certificate is obtained by improper means, such as deception and bribery, altering, reselling, renting, lending or transferring the registration certificate of food for special medical purpose, in addition to corresponding penalties, the penalty of announcing to the public has also been supplemented to the relevant clauses. The Draft increased the penalties for violations, regulated applicants to strictly implement legal requirements and be responsible for the authenticity of the application documents.

8. Conclusion

The Measures for the Registration of Food for Special Medical Purpose (Draft for Comments) is currently in the stage of soliciting opinions. The deadline for feedback is November 18, 2021. The Draft clarified that the products applied for registration need to carry out on-site verification and sampling inspection, newly supplemented termination of review, and 9 situations of denying registration. It is recommended that all relevant enterprises learn about the laws and regulations in advance to facilitate their better development.

Through the interpretation, Antion hopes to help food for special medical purpose enterprises and industry-related personnel better understand the changes in regulations and standards, as well as regulatory trends, and provide reference for the next step of work. At the same time, Antion can provide services such as standards and regulations consultation and food label review. If any questions, please feel free to contact us!

 If you are interested, please feel free to contact us!

Source: Antion

Note: This article is compiled by Antion, please indicate our source if reprint it.