Interpretation on China Health Food Registration Application Service Guideline

No.

List of domestic products registration dossiers

Specific requirements

1

Health food filing application form; Letter of commitment for authenticity of the materials;

• Fill in the registration form through the health food registration application system under CFDA and print the application form.

2

Copies of legally registered certificates of the applicant;

• Provide the Enterprise Legal Person Business License or Public Institution Corporate Capacity Registration Certificate

3

Product development report

• A safety confirmation report in which usage basis of the active ingredients and the excipients, the safety of active ingredients compatibility and their daily intake, the analysis of safety evaluation test material, the safety summary of the suitable groups, the unsuitable groups, edible methods, daily intake and matters need attentions shall be included;
• A health function confirmation report in which the health function scientific proof of the main active ingredients and the non-main active ingredient compatibility are necessary, the health function scientific proof of active ingredients compatibility and their daily intake, the analysis of health function evaluation test material and the crowd edible evaluation material, the health function summary of the suitable groups, the unsuitable groups, edible methods and daily intake shall be included;
• A production process development report in which the determine basis of dosage form and fill weight, usage basis and dosage basis of the excipients, development report of the main production process and critical process parameters that influence product safety and health function, 3 batches pilot scale production validation and self-test reports for domestic products and 3 batches large-scale production validation and self-test reports for initial imported products (PS: If process development information in laboratory and pilot scale are missing or incomplete, at least 10 batches large-scale production validation reports and testing reports should be provided for initial imported products.), production process of the active ingredients with no government standard, processing agent quality requirements in the product, the process information summary about product process compatibility shall be included.
• Research report on the products technical requirements in which the research on the identification methods, determine basis on physicochemical index and the test methods, determine basis on functional components/ characteristic ingredients index, determine basis on content uniformity or weight variation, quality requirements of active ingredients and excipients and evaluation of products stability (including the review of storage method, test items, test methods and stability test results);Products technical requirements (sample manuscript) shall be included.

4

Products formulation material

• Provide the formula table (include the name, dosage of active ingredients and excipients), quality requirements, production process, test qualification certificate (COA) of the active ingredients and excipients.

PS: Dosage of raw materials and excipients refers to dosage that may produce 1000 minimum preparation unit.

5

Production process material

• Provide the main producing flow chart and detailed instructions, key process control points and instructions.

6

Safety and health function assessment material;

• Legal qualification certification of food test institution.
• Safety test assessment dossier issued by legal qualification test institution;
• Health function test assessment dossier issued by legal qualification test institution;
• the crowd edible evaluation material issued by legal qualification test institution (Involve the human health function test);
• 3 batches products tests reports of functional components/characteristic ingredients, hygiene health and stability issued by legal qualification test institution;
• Strain identification report issued by authority test institution and strain virulence test report for Probiotics-based Health Food issued by legal qualification test institution;
• Stimulants, illicit drugs test report for Health Food with Relieving physical fatigue, Weight loss or Improving growth and development function issued by legal qualification test institution.

7

Information of packaging materials in direct contact with the product

• Type, name, quality standard number, quality standard text and use basis of packaging materials in direct contact with the product

8

Samples of product label and package insert

• Samples of product label and package insert (sample manuscript) include: active ingredients, excipients, functional components/characteristic ingredients as well as the contents, suitable crowds, unsuitable crowds, health function, daily intake, edible method, fill weight, storing method, shelf life and matters need attention.

9

Retrieval information (retrieved from CFDA government website database)

• Search materials of which the generic name and the name of registered drug are not the same shall be searched and printed through CFDA database.
• Search materials of which the generic name and the name of registered health food are not the same shall be searched and printed through CFDA database.
• If product uses the words showing the product characteristics and does not use the raw material name as the generic name, naming explanation should be provided;
• If product uses a registered trademark, the trademark registration certificate should be provided.

10

3 samples with the minimum sales packaging

• The package, label and specification of samples for imported product shall be corresponding with product on the original market.
• The samples shall be no less than 3 months from the expiry date.

11

Other relevant materials

• Include proof documents, such as enterprise quality control system proof (GMP, HACCP) copies, original power of attorney, original literatures copies.

No.

Except above dossiers, registration application on initial imported product also should submit following documents:

1

• Qualification certifying documents issued by government authorities or legal service agencies in the producing country (region) of origin proving that the registration applicant is the oversea manufacturer of the health food marketed;

2

• Certifying documents issued by government authorities or legal service agencies in the producing country (region) of origin proving that the product has been marketed more than a year, or safety report of oversea sales and consumer’s feedback;

3

• Health food-associated standards issued by the product producing country (region) of origin or international organizations;

4

• Packaging, labels, package inserts for products marketed in the producing country (region) of origin;

5

• For registration affairs run by oversea manufacturer’s Permanent Representative in China, a copy of the "Registration certificate of Overseas Pharmaceutical Manufacturers’ Permanent Representative Agencies in China" shall be provided;
• For registration affairs run by domestic agencies entrusted by oversea manufacturers, the applicant shall provide the original notarized certificate of entrustment and copies of business license of the agencies entrusted.