CIRS FAQ: Does changing the product’s raw material supplier require a product change application?

From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on food for special medical purposes (FSMP) to help you gain a clearer understanding of the current requirements in China.

Q1: In the registration materials for FSMP, what exactly does the phrase “product has been marketed” mean? Does it include products that have already been marketed domestically under other food categories or products that have been marketed abroad?

A1: “Applicants with products already on the market” refers to domestic applicants who have obtained a food production license, or overseas applicants who have obtained import qualifications for FSMP. “Products already on the market” includes both those that are marketed domestically and abroad. Additionally, if the product has been marketed under other food categories, it is beneficial to specify these categories in the application materials. This helps reviewers better understand the product and speeds up the review process.

Q2: Does changing the product’s raw material supplier require a product change application? What steps need to be taken?

A2: Generally, this is not required.

When a company changes one of its raw material suppliers, provided that the raw material variety remains unchanged, the product’s ingredient list order and nutritional information remain the same (as stated in the registration certificate and its attachments), and the change does not affect the product's safety, nutritional adequacy, or clinical efficacy for its special medical purpose, then such application is not required.

The company must establish a raw material supplier management system, including supplier change management. First, verify the supplier’s qualification documents to ensure they meet the required standards. Next, review or test the relevant certification documents for the raw materials to confirm they meet the company’s acceptance standards. Additionally, conduct small-scale trials and sample tests after changing the formula ingredients to ensure that the new raw materials from the new supplier meet production process requirements.

Q3: What essential equipment is required for the research and development (R&D) institutions of infant formulas for special medical purposes? Which basic R&D tasks can be supported by collaboration with the parent company, universities, or research institutes?

A3: The required R&D equipment differs for powder and liquid products.

Powder products: weighing, mixing, drying, packaging, testing, and stability testing equipment.

Liquid products: weighing, dissolution, homogenization, sterilization, filling, testing, and stability testing equipment.

Applicants should establish R&D institutions for FSMP. While process validation for pilot batches should be conducted at the production facility, foundational R&D work can be carried out within the company’s group or in collaboration with universities and research institutes. Leveraging the basic and applied research strengths of these institutions, companies can explore industry-academia collaboration models to optimize product formulas, use new raw materials, technologies, and advanced testing methods, and enhance innovation in product varieties, forms, flavors, and packaging.

Q4: Are there requirements for sample size and intervention duration in clinical trials for specific nutritionally complete formulas?

A4: Yes.

Sample size requirements:

• According to the Clinical Trial Quality Management Guidelines for Foods for Special Medical Purposes issued by the State Administration for Market Regulation (SAMR) on April 9, 2024, the sample size of participants should meet statistical requirements, with a description of the calculation basis and reasons, and provide relevant trial or literature data. However, specific sample size numbers are not stipulated.
• The Technical Guidance Principles for Clinical Trials of Specific Nutritionally Complete Formula for Kidney Disease, Technical Guidance Principles for Clinical Trials of Specific Nutritionally Complete Formula for Cancer, and Technical Guidance Principles for Clinical Trials of Specific Nutritionally Complete Formula Foods for Diabetes stipulate that “participants should be randomly assigned to either the experimental group or the control group. The number of effective cases in the experimental group should generally be no less than 100, with a dropout rate not exceeding 20%. Sample size should be estimated using appropriate statistical methods based on the main research endpoints of the clinical study.” Therefore, clinical trials for these three specific complete nutrition formula foods must meet these sample size requirements.

Trial duration requirements:

It’s stated in the Clinical Trial Quality Management Guidelines for Foods for Special Medical Purposes that “The trial duration and specific arrangements, including visit and follow-up schedules, should be determined based on the research objectives and the biological characteristics of the primary laboratory indicators being studied. The observation period should be appropriately set to meet statistical requirements.”

The Technical Guidance Principles for Clinical Trials of Specific Nutritionally Complete Formula for Kidney Disease specify that “The trial duration should be no less than 4 weeks.” The Technical Guidance Principles for Clinical Trials of Specific Nutritionally Complete Formula for Cancer state that “For samples used as the sole source of nutrition, the trial duration should be at least 7 days; for samples used as partial nutritional supplementation, the duration should be at least 2 weeks.” The Technical Guidance Principles for Clinical Trials of Specific Nutritionally Complete Formula for Diabetes indicate that “For samples used as the sole source of nutrition, the trial duration should be at least 7 days; for samples used as partial nutritional supplementation, the duration should be at least 4 weeks.” Therefore, clinical trials for these specific nutritionally complete nutrition formula must adhere to these duration requirements.

For more information about the registration of FSMP in China, please click here to learn about our FSMP registration service.

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