Registration Process for Foods for Special Medical Purposes (FSMP) in China

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About Food for Special Medical Purposes (FSMP)

Food for Special Medical Purposes (FSMP) refers to formula foods designed to meet the special nutritional needs of individuals with restricted eating, digestive and absorption disorders, metabolic imbalances or specific disease conditions. In China, FSMP must be consumed under the guidance of a doctor or a nutritionist and are classified into three categories based on their functions.

Full nutrition formula food: Can serve as the sole source of nutrition.
Specific full nutrition formula food: Targeted at specific diseases or medical conditions.
Non-complete nutrition formula food: Only serves as a partial nutritional supplement.

China's FSMP Regulatory System

As a special category of food, FSMP is subject to strict legal supervision due to the nutritional needs of specific groups and its uses. The following are the core regulatory documents of China's FSMP system:

Food Safety Law of the People's Republic of China
Good Manufacturing Practices for Foods for Special Medical Purposes
National Food Safety Standard: General Standard for Foods for Special Medical Purposes
Guidelines for Labelling of Foods for Special Medical Purposes
Quality Management Standards for Clinical Trials of Foods for Special Medical Purposes
Administrative Measures for Registration of Foods for Special Medical Purposes
Key Points and Compliance Criteria for On-Site Inspections of Clinical Trials in Registration of Foods for Special Medical Purposes

Registration Process for FSMP in China

1. Preparation Phase

Product development and data collection

Determine the product formula, nutrient content and functional uses, ensuring compliance with regulatory requirements.
Design and validate the production process to ensure controlability and consistency.
Design a trial plan that conforms to medical ethics and scientific norms, and conduct clinical trials in China to verify the medical uses and safety of the product.
Carry out stability studies and submit relevant data.

Confirm registration qualifications

Chinese enterprises: Must have legal production qualifications and pass GMP review.
Import enterprises: Must establish an agency in China and provide production licenses and compliance documents from the exporting country.

The sponsor should conduct an in-depth study of relevant regulatory provisions. If necessary, communicate with the SAMR or relevant technical review departments to clarify the specific requirements.

2. Submitting the Registration Application

The sponsor submits the registration application through the FSMP management system, fills out the application form and uploads complete electronic materials.

Special Medical Purpose Formula Food Registration Application Form
Applicant's entity qualification documents
Product development report
Product formula and design basis
Production process documentation
Product standards and technical requirements
Product label and specification draft samples
Product inspection report
Materials demonstrate the applicant's research and development capabilities, production capacity and inspection capabilities.
Other materials indicate the product's safety, nutritional adequacy and clinical effectiveness for special medical purposes.

For the registration of complete nutrition formula foods, a clinical trial report is generally also required.

3. Formality Review

The SAMR conducts a completeness check on the submitted materials to ensure that they are complete and comply with the form requirements. Generally, if the application materials are incomplete, the applicant will be requested to provide all the necessary information within five days. If no correction notice is received, it will be assumed acceptance from the date of receiving the application materials.

4. Technical Review

In most cases, the SAMR completes the technical review within 60 days. If additional materials are required, the applicant must submit the corrected materials within 6 months.

5. On-site Inspection

The applicant shall confirm the on-site inspection date within 30 working days. The review agency will conduct the inspection within 20 working days after confirmation and issue the production site inspection report.

During on-site verification, the review agency collects samples from dynamic production and assigns a qualified food inspection institution to perform testing. The inspection will complete within 30 working days of sample receipt, followed by an inspection report.

For clinical trial verification of specific full nutrition formula food registration, the review institution completes the on-site assessment within 30 working days of the applicant’s confirmation and issues a report.

6. Registration Decision

SAMR makes a registration approval decision within 20 working days. Upon approval, the registration certificate will be issued within 10 working days with a 5-year validity period. If rejected, the applicant will receive a written notice detailing the reasons and may reapply after implementing corrective measures.

Our Services

Proregulations has a professional compliance expert team and a mature service process, providing comprehensive regulatory support for the registration of China's FSMP.

We offer the following related services:

Regulatory consultation and training
Product formula assessment
Product label review
Regulatory consultation
FSMP compliance review
FSMP application materials preparation
FSMP application submission
Risk management
Post-market compliance support

Proregulations fully understands the significance and complexity of the FSMP registration process in China. We have always provided professional services to help our clients' products enter and successfully establish a presence on the Chinese market. If you are interested in our services, please contact us.