China - Priority Review and Approval Procedures for Special Medical Purpose Formula Food Registration
Published 30 October 2024
Sarah Xuan
To encourage innovation and meet urgent clinical nutrition needs, the State Administration for Market Regulation (SAMR) has issued the Priority Review and Approval Procedures for Special Medical Purpose Formula Food Registration (hereinafter referred to as the “Procedures”). This article provides a detailed interpretation of the scope of application, work procedures, and implementation requirements for industry professionals engaged in special medical purpose formula (SMPF) foods.
I. Background of the Procedures
In December 2023, SAMR revised the Administrative Measures for the Registration of Special Medical Purpose Formula Food (hereinafter referred to as the “Measures”) by adding provisions related to priority review and approval. These new provisions enable enterprises to apply for priority registration procedures for SMPF products specifically designed for rare diseases or new types of clinically urgent products that have not yet been approved.
II. Scope of Application
In accordance with the Food Safety Law of the People’s Republic of China and its Implementation Regulations, as well as the Measures, the following categories of SMPF products are eligible for priority review and approval:
1. SMPF for Rare Diseases:
This includes products addressing diseases such as phenylketonuria, maple syrup urine disease, and urea cycle disorders.
2. New Types of Clinically Urgent SMPF Products:
Examples include complete nutrition formulas for diabetes, respiratory diseases, kidney disease, liver disease, and gastrointestinal absorption disorders or food protein allergies.Other Situations:
3. SAMR may designate other categories of products based on special needs for priority review and approval.If an SMPF product falls into any of these categories and meets the specified requirements, enterprises may apply for the priority review and approval procedures.
III. Work Procedures
1. Application Submission
When submitting the registration application for an SMPF product, enterprises must also submit the Application Form for Priority Review and Approval (attached to the Procedures). This form must be uploaded electronically through the SMPF registration system.
2. Acceptance and Public Notification
1) Preliminary Review and Acceptance
The Food Review Center (hereinafter referred to as the Review Center) will conduct a preliminary examination of the submitted materials. If the application is complete and meets the priority review conditions, it will be accepted. If the application does not meet the requirements, the enterprise will receive a written notification, and the application will proceed under the standard review process.
2) Unified Numbering and Sorting
All applications accepted under the priority procedures will be assigned unified serial numbers in the order of acceptance. Priority applications will be sorted independently based on the time of acceptance.
3) Public Notification and Handling of Objections
Information regarding the accepted applications, including applicant name, product name, registration number, and the reason for priority review, will be publicly posted for 5 working days.
If there are objections during the public notification period, stakeholders must submit an Objection Form with supporting reasons. The Review Center will handle objections within 10 working days and notify the applicant and the party raising the objection of the result.
3. Technical Review and On-Site Inspections
1) Technical Review and Expert Consultation
The Review Center will conduct technical reviews and, where necessary, consult experts. The review process must be completed within 30 working days. If required, the Review Center will arrange special communication sessions to help applicants understand the review requirements.
2) On-Site Inspections and Sampling
For products that require on-site production inspections or sampling, these activities will be prioritized. In the case of specific complete nutrition formulas, clinical trial site inspections will also be prioritized.
4. Termination of Priority Review Procedures
1) Termination Conditions
If it is determined during the review that the product no longer qualifies for priority review (e.g., a similar product has been approved), the priority review procedure will be terminated.
2) Post-Termination Process
The Review Center will notify the applicant in writing of the termination and continue the review process under the standard procedures.
IV. Implementation Requirements
1. Communication and Feedback
Applicants can submit communication requests through the center’s email address. Besides, requests should include the product name, registration number, and a description of the issues to be addressed. The Review Center will arrange personnel to respond to these requests promptly.
2. Reporting Issues
If any issues arise during the implementation of the Procedures, applicants should promptly report them to the Special Food Safety Supervision Department of SAMR to ensure smooth execution of the procedures.
[Summary and Comments]
The Procedures aim to streamline and accelerate the registration process for SMPF products, addressing urgent clinical nutrition needs efficiently. For enterprises, understanding and leveraging the priority review policies is essential to drive innovation and expand market presence. During the application process, it is crucial to ensure that submitted materials are complete and compliant with regulatory requirements and to maintain effective communication with the Review Center.
Through this green channel established by SAMR, the registration process for critical SMPF products can be expedited, offering greater support for patients with rare diseases and others in urgent need. Moving forward, enterprises should focus on product innovation and take advantage of regulatory policies to accelerate the development and launch of new products.
I. Background of the Procedures
In December 2023, SAMR revised the Administrative Measures for the Registration of Special Medical Purpose Formula Food (hereinafter referred to as the “Measures”) by adding provisions related to priority review and approval. These new provisions enable enterprises to apply for priority registration procedures for SMPF products specifically designed for rare diseases or new types of clinically urgent products that have not yet been approved.
II. Scope of Application
In accordance with the Food Safety Law of the People’s Republic of China and its Implementation Regulations, as well as the Measures, the following categories of SMPF products are eligible for priority review and approval:
1. SMPF for Rare Diseases:
This includes products addressing diseases such as phenylketonuria, maple syrup urine disease, and urea cycle disorders.
2. New Types of Clinically Urgent SMPF Products:
Examples include complete nutrition formulas for diabetes, respiratory diseases, kidney disease, liver disease, and gastrointestinal absorption disorders or food protein allergies.Other Situations:
3. SAMR may designate other categories of products based on special needs for priority review and approval.If an SMPF product falls into any of these categories and meets the specified requirements, enterprises may apply for the priority review and approval procedures.
III. Work Procedures
1. Application Submission
When submitting the registration application for an SMPF product, enterprises must also submit the Application Form for Priority Review and Approval (attached to the Procedures). This form must be uploaded electronically through the SMPF registration system.
2. Acceptance and Public Notification
1) Preliminary Review and Acceptance
The Food Review Center (hereinafter referred to as the Review Center) will conduct a preliminary examination of the submitted materials. If the application is complete and meets the priority review conditions, it will be accepted. If the application does not meet the requirements, the enterprise will receive a written notification, and the application will proceed under the standard review process.
2) Unified Numbering and Sorting
All applications accepted under the priority procedures will be assigned unified serial numbers in the order of acceptance. Priority applications will be sorted independently based on the time of acceptance.
3) Public Notification and Handling of Objections
Information regarding the accepted applications, including applicant name, product name, registration number, and the reason for priority review, will be publicly posted for 5 working days.
If there are objections during the public notification period, stakeholders must submit an Objection Form with supporting reasons. The Review Center will handle objections within 10 working days and notify the applicant and the party raising the objection of the result.
3. Technical Review and On-Site Inspections
1) Technical Review and Expert Consultation
The Review Center will conduct technical reviews and, where necessary, consult experts. The review process must be completed within 30 working days. If required, the Review Center will arrange special communication sessions to help applicants understand the review requirements.
2) On-Site Inspections and Sampling
For products that require on-site production inspections or sampling, these activities will be prioritized. In the case of specific complete nutrition formulas, clinical trial site inspections will also be prioritized.
4. Termination of Priority Review Procedures
1) Termination Conditions
If it is determined during the review that the product no longer qualifies for priority review (e.g., a similar product has been approved), the priority review procedure will be terminated.
2) Post-Termination Process
The Review Center will notify the applicant in writing of the termination and continue the review process under the standard procedures.
IV. Implementation Requirements
1. Communication and Feedback
Applicants can submit communication requests through the center’s email address. Besides, requests should include the product name, registration number, and a description of the issues to be addressed. The Review Center will arrange personnel to respond to these requests promptly.
2. Reporting Issues
If any issues arise during the implementation of the Procedures, applicants should promptly report them to the Special Food Safety Supervision Department of SAMR to ensure smooth execution of the procedures.
[Summary and Comments]
The Procedures aim to streamline and accelerate the registration process for SMPF products, addressing urgent clinical nutrition needs efficiently. For enterprises, understanding and leveraging the priority review policies is essential to drive innovation and expand market presence. During the application process, it is crucial to ensure that submitted materials are complete and compliant with regulatory requirements and to maintain effective communication with the Review Center.
Through this green channel established by SAMR, the registration process for critical SMPF products can be expedited, offering greater support for patients with rare diseases and others in urgent need. Moving forward, enterprises should focus on product innovation and take advantage of regulatory policies to accelerate the development and launch of new products.