CFDA Issued the Administrative Measures of Foods for Special Medical Purpose (FSMP) Registration

Update on 22 July 2016

With the growth and aging of China's population, the patients of clinical diseases, such as the diabetes, kidney disease, cancer, obesity, chronic obstructive pulmonary disease, and amino acid metabolic disorders, gradually increased and they have demands for special nutrients or dietary food. Foods for Special Medical Purpose (FSMP) are made from special processing formula and used to meet the special dietary need for people who have limited feeding, digestion absorption disorders, metabolic disorders or specific disease condition. FSMP was registered as drug in China before and the high registration fee causes high price to limit its development in China. To meet clinical demands of FSMP and reduce the economic burden for patients, the Chinese government is gradually set up related supporting regulations in line with international standards,

CFDA released the Administrative Measures of FSMP Registration (trial)on March 7, 2016, and it was implemented on July 1, 2016. Now the CIRS provide the detailed explanation.

1.What is the use scope of FSMP?

FSMP must be used alone or with other food under the guidance of the doctors or clinical nutritionists. FSMP belongs to food, not drugs, and cannot be a substitute for drugs. So this kind of products cannot be claimed for disease prevention and treatment function.

Country or Organization

Chinese name

English name

The Codex Alimentarius Commission(CAC)

特殊医学用途食品

Foods for Special Medical Purpose

EU(European Union)

特殊医学用途膳食食品

Dietary foods for special medical purposes

America & Canada

医用食品

Medical Foods

Australia

特殊医学用途食品

Foods for Special Medical Purpose

Japan

病人用特别用途食品

特別用途食品(Japanese name)

China

特殊医学用途配方食品

Foods for Special Medical Purpose

2.What kinds of FSMP required to be registered?

Age Groups

Categories

Concrete Implication

FSMP for the age 1 year older and above.

Full nutritional formula food

These products can be used as a single source of nutrition for targeted population requirements.

Specific Full nutritional formula food

These products can be used as a single source of nutrients to meet targeted groups requirements in a particular disease or medical condition. There are 13 categories of specific full nutritional formula foods below: 1. Full nutritional formula food for diabetics; 2. Full nutritional formula food for respiratory system disease patients, 3. Full nutritional formula food for kidney disease patients; 4. Full nutritional formula food for cancer patients; 5. Full nutritional formula food for hepatopaths, 6. Full nutritional formula food for muscle attenuation syndrome patients, 7. Full nutritional formula food for patients with trauma, infection, surgery or other stress condition, 8. Full nutritional formula food for patients with inflammatory bowel disease; 9. Full nutritional formula food for food protein allergy sufferers;10. Full nutritional formula food for patients with intractable epilepsy; 11. Full nutritional formula food for patients with gastrointestinal disorders, pancreatitis; 12. Full nutritional formula food for patients with fatty acid metabolism, 13. Full nutritional formula food for patients with obesity, fat reducing surgery.

Part nutritional formula food

These products can be used to meet the targeted population requirements of part nutrition and cannot be a single source of nutrients. There are 5 categories of part nutritional formula food below: nutrient components (protein components, fat components, carbohydrate components), the electrolyte formula, thickening components, liquid formulation and amino acid metabolism disorder formula.

FSMP for 0 to 12 months old infant.

No lactose formula or low lactose formula food

Partially hydrolyzed milk protein formula food

Completely hydrolyzed milk protein formula food or amino acid formula food

Premature delivery or low birth weight infant formula food

Amino acid metabolism disorder formula food

Breast milk nutritional supplements

3.What are related national standards about FSMP?

S.N.

National standards

1

The General Rules of Foods for Special Medical Purpose (FSMP)  (GB 29922-2013)and related Q&A.

2

Food Safety National Standards for the General Rules of Infant Formula Foods for Special Medical Purpose (FSMP)  (GB 25596-2010) and related Q&A.

3

Good Manufacturing Practices of Foods for Special Medical Purpose (FSMP) (GB 29923-2013)

4

Food Safety National Standards for Labeling of the Prepackaged Foods for Special Dietary uses(GB13432-2013)

5

The Administrative Measures of Foods for Special Medical Purpose (FSMP) Registration (trial)

6

Clinical Trials Quality Control Specifications of Foods for Special Medical Purpose (FSMP)

7

The Administrative Measures of Food Production License

8

The Administrative Measures of Food Operation License

9

The Provisional Regulations on Food Advertising (revised)

10

Advertisement Law of People’s Republic of China (2015 version)

11

Food Safety National Standards for the Uses of Food Additives(GB 2760-2014)

12

Application Materials and Requirements of Foods for Special Medical Purpose (Trail)

13

Label and Specification Samples of Foods for Special Medical Purpose (Trail)

14

Stability Research Requirement of Foods for Special Medical Purpose (Trail)

15

Spot Inspection Point and Judging Principle for Manufacturer of Foods for Special Medical Purpose (Trial)

4.What requirements dose the applicants have to meet to apply for FSMP registration?

Only the FSMP manufacturers could apply for FSMP registration. Meanwhile, the applicants above must meet all the following three requirements:

(1) Set up the independent R&D institutions and should be equipped with full-time product R&D personnel, food safety executive personnel and food safety professional and technical personnel;

(2) According to good manufacturing practices standards requirements, establish corresponding production quality management system;

(3) Have the ability to complete all test items according to the Food Safety National Standard (GB) for FSMP.

5.Which kinds of FSMP need clinical trials?

All the specific full nutritional formula foods should be completed the clinical trials, but other categories of FSMP do not need to do clinical trials.

6.What are qualified clinical trial methods and the technical indicators based on?

The Clinical Trials Quality Control Specifications of Foods for Special Medical Purpose (FSMP) are the basis for qualified clinical trial methods and the technical indicators. These specifications will be released by CFDA.

7.How many clinical test institutions are there?

Applicants can select several clinical trial institutions to do clinical test and the lead institutions and the statistical institutions should be clear. The clinical trial institutions may be certificated and released by CFDA later.

8.How many sampling test institutions are there?

The list of FSMP sampling test institutions will be released by CFDA.

9.What content the on-the-spot inspections have?

CFDA will inspect R&D ability, production ability, test ability and so on by reviewing the materials, paying a return visit to the clinical trials crowds and other ways.

10.What contents are listed in the eye-catching place of FSMP label and instruction?

All the following contents should be appeared:

(1) This product should be used under the guidance of doctors or clinical nutritionists;

(2) This product is only used for the targeted population;

(3) This products cannot be used for parenteral nutrition support and intravenous injection.

11.The procedures of FSMP registration.

Note: The on-the-spot inspection for overseas manufacturer for overseas manufacturer will depend on specific situation.

12.The required materials of FSMP registration

No.

Registration required materials

1

The application form of FSMP registration

2

Products R&D reports, formula materials and formula design basis

3

Product process materials

4

Product standard requirements

5

Product labels and manual sample

6

Test reports

7

Evidence materials of R&D ability, production ability and test ability

8

Other evidence materials of product safety and nutritional adequacy

9

Clinical trial reports (only specific full nutritional formula foods do clinical trials )

10

Certifying documents for imported FSMP registration

10.1

If the product has registered brand, it shall provide the copy of brand registration certificate. The certificate shall be issued by Trademark Office of the State Administration for Industry & Commerce of the People’s Republic of China and the brand application scope shall meet the standard.

10.2

The copies of the qualification documents and Chinese translations for overseas manufacturers issued by original country authority or legal institute, in case the applicant is a foreign enterprise. 

10.3

The copy of license showing that the product is permitted for sale in original country (region) and its Chinese translation. If the product hasn’t gone on sale yet, the license is not mandatory.

10.4

The materials proving that the product manufacturer complies with the relevant manufacturing quality management regulations and/ or relevant quality control system.

10.5

When the registration of imported FSMP is to be applied/altered/renewed, the applicant can be a representative office in China or an agent institute in China. If the applicant is representative office in China, the copy of registration certificate for overseas enterprise representative office in China is required. If the applicant is agent institute within China, notarized letter of commitment (and its Chinese translation) and business license of agent institute shall be submitted in addition.

11

Other relevant materials

11.1

Retrieval materials in which the trade names of the products do not share the same name with the drugs,health food and FSMP approved for registration. Retrieval explanation in which the product formula do not overlap with the drugs, health food approved for registration.

11.2

The patent situation relevant to the registered products and the ownership status statement as well as the warranty promising that the patent of the products does not infringe the patent of others.

11.3

In case the imported FSMP do not go on sale in the manufacturing country (region), documents explaining why the products are not sold in the manufacturing country (region) shall be submitted.

11.4

Documents that are used to certify the legitimate source of the food raw materials, food additives and the packing materials, such as the main body registration certification documents of the material manufacturing enterprises, sales invoice, duplicate of delivery inspection report and factory inspection report, etc.    

11.5

In case one enterprise applies for registration again after its product is revoked, the enterprise shall submit the duplicate of the registration disapproval decision.

This new regulation of FSMP registration simplifies the registration procedure and shortens the registration duration to provide more opportunities and convenience for manufacturers to enter into Chinese market.

 If you have any other questions, please feel free to contact us at service@cirs-reach.com.