Requirement for China Health Food Registration Dossier

On 8th June 2016, China Food and Drug Administration (CFDA) published Requirement for Health Food Registration Dossier (for public comment), hereinafter called “Draft”. The Draft includes format requirement for application dossier, general requirement for application dossier, nomenclature and definition, registration application dossier items and requirements (appropriate for new product, altering product, renewing product and product belonging to vitamin, mineral or other nutriment supplements), registration dossier requirements for product containing extracts  and so on. CIRS analyzes the requirements for main application dossiers and make a conclusion as following shows:

1. Format requirement and general requirement for application dossier

CFDA will conduct formal examination of the dossier before accepting health food registration application dossier. If the dossier is not in accordance with following format requirements or general requirements, CFDA will require applicant to supplement or amend materials.

No.

Format requirement for application dossier

1

-        The first page of the dossiers is a list of the application documents;

-        Each dossier item shall has its cover page (indicating product name, applicant name and material name);

-        Different dossiers shall be distinguishable with clear markers;

-        The full set of dossier should be punched and bound into a book.

2

-        The application dossiers shall be printed in A4 size paper;

-        Chinese characters shall be no less than font-size junior 4 in Song typeface;

-        English shall not be less than font-size 12.

3

-        Application dossiers (except application form and testing report issued by testing institutions) shall be stamped with applicant seal page by page;

-        The seal shall be stamped in the text place.

4

-        Certificate, label and specification with foreign languages, abstract and keyword in foreign references should be translated into standard Chinese;

-        Product information about safety, health function and quality control shall be translated into standard Chinese.

5

-        Original, copy and electronic version of application dossiers should be submitted;

-        The content on the copy and electronic version should be consistent with original dossier;

-        Registration application dossier shall consist of 1 original dossier and 7 copies.

6

-        Registration application form, product formulation, label, specification and product technical requirement should be filled in online and then printed.

-        Other registration materials should be stamped with company seal page by page, and then be scanned to electronic version. Finally, upload them to Health Food Registration Application System.

7

-        Applicant shall submit supplement materials in order according to request of Notice about Health Food Evaluation Opinion and the Notice shall be attached behind supplement material.

No.

General requirement for application dossier

1

-        Scientific proof about technical requirement (formula, process, etc.);

-        Scientific proof about product safety, health function, quality control, etc.

2

-        Sample for testing and research shall be prepared by pilot scale process, and the workshop and manufacturing process shall comply with GMP.

-        The sample for initial imported registration application must have been sold in manufacturing country (region).

3

-        Applicant shall provide research/testing beginning and ending time, testing site and purpose, method, basis, process, result, conclusion of research or testing, testing department and tester’s signature and seal.

4

-        Original research and testing record, instrument and equipment usage record, and original pilot scale production record should be kept regularly in case authority inspects.

5

-        Sublingual absorption agent, spray, slow-release preparation, controlled-release preparation, enteric agents, dropping pill and so on cannot be classified as health food in general.

6

-        One enterprise cannot register one formula with different health food names and cannot register one product name for different formula health foods.

7

-        In principle, appropriate crowds of registration application product cannot be infants, pregnant women and nursing mother.

2. Items and requirements of new products registration dossiers

CFDA Health Food Evaluation Center will technically review the dossiers submitted for health food registration. If dossiers that do not meet the requirements are found, CFDA Health Food Evaluation Center may require applicant to supplement or amend their registration dossiers.

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

-        Have explicit and compliant basis for the safety of documents and excipients of products;

-        A safety confirmation report in which the safety of products, 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 of products, the suitable groups, the unsuitable groups, edible methods, daily intake and matters need attentions shall be included;

-        For domestic products, information of the whole process including the technical study in laboratory, pilot scale technical verification and technology modification shall be provided; for initial imported products, the information of the whole process including technical study in laboratory and scale production shall be submitted.

-        Research on the products technical requirements (including the research on the identification of principal raw materials relevant to functions, research on physicochemical index, research on functional components or characteristic ingredients index, content uniformity or weight variation and quality requirements of raw materials and excipients.

-        Review of products stability (including the review of storage method, packing materials that may directly contact products, shelf life and other indexes that are easy to change along with the change of storage conditions and time);

-        Products technical requirements will be determined according to the R&D results (sample manuscript)

4

Products formulation material

-        Provide the name, dosage, production process, quality requirements, test qualification certificate (COA) of the raw materials and excipients.

5

 Production process material

-        Provide the main producing flow chart and detailed instructions. Dosage of raw materials and excipients refers to dosage that may produce 1000 minimum preparation unit.     

6

Safety and health function assessment material;

-        Safety test assessment dossier of raw materials

-        Safety and function assessment material; and tests reports of functional components/characteristic ingredients, stability, hygiene health and others if necessary;

-        Strain identification and strain virulence test report for Probiotics-based Health Food; Stimulants, illicit drugs test for Health Food with Relieving physical fatigue, Weight loss or Improving growth and development function.

7

Information of packaging materials in direct contact with the product (Type, name and relevant standards);

-        Determine comprehensive assessment according to the manufacturing technique research and the stability of products

8

Samples of product label and package insert as well as materials of which the generic name and name of registered drug are not the same

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

-        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.

9

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.

10

Other relevant materials

-        Include proof documents, such as enterprise quality control system proof (GMP, HACCP), power of attorney, original testing report of raw material, research report, original literatures and so on.

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.

3. Registration application dossier items and requirements for product belonging to vitamin, mineral or other nutriment supplements

If the vitamin and mineral nutrition supplements are not complying with requirements of Health Food Raw Material Directory, then the products cannot be filed and shall get registered. In the following circumstances, vitamin and mineral nutrition supplements are considered as not complying with the requirements of Health Food Raw Material Directory:

  • The daily intake of vitamins and minerals is not in conformity with that listed in the Health Food Raw Material Directory;
  • Compounds of the vitamins or minerals that are not listed in the Health Food Raw Material Directory;
  • The supplemented vitamins and minerals are not listed in the Health Food Raw Material Directory; and
  • Vitamins and minerals that are extracted from edible part of the food.

PS. Health function tests assessment materials can be exempted during the process of registering vitamin and mineral nutrition supplements.

4. Registration dossier requirements for product containing extracts

CFDA has two extra requirements for health food made from extracts due to the particularity of the extracts.

No.

Requirements for dossiers

Specific requirements

1

Requirements for formula, safety and function

-        Compared with raw materials or with the extracts extracted through water extraction, alcohol extraction and other traditional techniques, if the chemical constituents, contents and other inherent quality of the extracts change apparently, safety assessment materials shall be prepared according to the requirements of new raw materials.

2

Technical requirements

-        Quality requirements for extracts are including: Source, manufacturing technique, extract rate and sense requirements, general quality control index (such as moisture, ash content and particle size), pollutant index (such as lead, total arsenic, total mercury, residue of extraction solvent), pesticide residue, characteristic ingredients index, microbiological indicator (including total bacterial count, coli group, molds and yeasts, staphylococcus aureus as well as salmonella), etc.;

-        Create indexes that can reflect the quality characteristics of extracts and explain the basis for choosing the indexes in details with reference to Chinese Pharmacopoeia, other related standards and extracts production process;

-        Submit total items self-test report of extracts according to the quality requirements..


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