China Foods for Special Medical Purpose: FSMP Premarket Approval Guidance

Recent Changes affecting Market Access

CFDA released the supplementary requirements for FSMP registration in China recently (see CL report on Apr. 19, 2016) to support of implementation of “Administrative Measures for Registration of Foods for Special Medical Purpose”.

The supplementary requirements include the detailed explanation of FSMP registration application materials, labeling requirements, clinical trial, stability testing, and production facility field inspection checkpoints.

1. Regulatory requirements

Under the new Food Safety Law, foods for special medical purpose (FSMPs) are regulated as special food in China, which requires registration with CFDA prior to entry into Chinese market.

2. Apply for pre-market approval

2.1 Registration procedure

2.2 Dossier requirements for FSMP registration

Content	Remarks
Application form	-
Product R&D report, product formula design and its evidence	1) Product formula 2) Product formula design and its evidence 3) Product R&D report
Production techniques	1) Production flowchart 2) Production technique statement 3) Statement to manufacturing site and equipment 4) Key point and quality control measures
Product standard requirements	Including product technical requirements
Product label and user’s direction	Chinese label and user’s directions are required for imported FSMPs.
Sample testing report	1) Three batches of sample testing report 2) Sample stability testing report 3) Other testing reports
Materials proving the capabilities of R&D, production and testing	-
Other materials indicating the product safety, nutrient sufficiency and the clinical effect of special medical purpose	For imported FSMPs, technical regulations or standards related to FSMPs of the producing country (district) shall be provided.
Clinical testing report	For the registration of nutritionally complete foods with a specific formulation
Copies of qualification certificates related to registration application	-
Other related materials	-

2.3 Requirements for stability research

The stability research materials and testing report should be submitted with the product registration application. Stability research shall be carried out for products in each category.

Stability research includes accelerated stability testing, and long-term stability tests. Other types of tests may be selected according to product characteristics, packaging and use conditions, including influencing factor test, stability test after product usage, etc.

The stability test items shall be carried out by the registration applicant in accordance with the testing methods specified in GB 25596 and GB 29922. In case that there is no testing method specified in national standards but are provided by the applicant, relevant methodology verification should be conducted and reported.

2.4 Requirements for clinical testing

Clinical testing is required for nutritionally complete foods with a specific formulation. Clinical testing must be carried out by medical institutes recognized by CFDA. The list accredited labs will be published by CFDA in the future.

2.5 Requirements for field inspection

Field inspection items are classified into 8 parts including production capacity, R&D capacity, inspection capacity, production place, equipment and facilities, personnel, materials management, production process management, with a total of 24 inspection items, among which there are 5 critical inspection items, including manufacturing qualification, R&D capacity, establishment of production quality management system, production condition, and water used for production. The other 19 items are for regular inspection.

There should be separate production lines for the manufacturing of FSMPs from other products. FSMPs with added probiotics should be produced in a separate workshop and production line to avoid microorganism contamination.

3. Design a compliant label

The labeling of FSMPs shall be in accordance with GB 25596, GB 29922, GB 7718 and GB 13432, and include the following information:

Content	Remarks
Product name	-
Product category	Product category should be determined according to GB 29922 and GB 29956.
Ingredient list	-
Nutrition facts	-
Product formula features (nutrition characteristics)	Including the explanation on the product for the disease or medical condition of the targeted users, interpretation of the formulation principle, etc.
Product property	-
Suitable group for consumption	All the suitable groups of people shall be indicated accurately.
Consumption method and dosage	-
Net content and specifications	-
Shelf life	-
Storage condition	-
Warnings and precautions	There should be indications of “use under the guidance of doctors or clinic dieticians”, and “this product is not suitable for non-targeted group of consumers”. For nutritionally complete foods, there should be indications of “this product is not suitable for the group of people with specific diseases”, “this product is prohibited for parenteral nutritional support”, etc.
Other requirements	1. The osmotic pressure shall be indicated for formula for premature delivery/low birth weight infants. 2. FSMPs for infants above 6 months should be labeled as “complementary food should be added for the infants above 6 months in special medical condition”. 3. The sentence “it can be consumed as the sole source of nutrients” or “it cannot be the sole source of nutrients and shall be consumed together with other foods” should be labeled.
Imported FSMPs	There should be samples of user’s directions, package and label for sale in the producing country (district) along with the Chinese version after notarization. In case the product has not been sold in the producing country (district), relevant statement should be provided.

Co-contributor of this article: Lavinia Yao