Interpretation on China Health Food Registration Application Service Guideline

On 23 December 2016, China Food and Drug Administration (CFDA) published a formal regulation called Health Food Registration Application Service Guideline (2016 Version) whose registration dossier is different from that listed in draft published on 8 June 2016 (hereinafter called new regulation). The new regulation includes registration application dossier items and requirements (appropriate for new product, altering product, renewing product and domestic products belonging to vitamin, mineral or other nutriment supplements, etc.) CIRS analyzes the requirements for main application dossiers and makes a conclusion as following:

1. Format requirement and general requirement for 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, testing report issued by testing institutions, notary documents, official certified documents and third party certified documents) shall be stamped with applicant seal page by page; The seal shall be stamped in the text place. If there is no seal for imported product registration applicant, the seal shall be replaced by legal representative signature or signature seal.
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 9 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, be scanned to electronic version and finally be uploaded to Health Food Registration Application System.
7	Applicant shall submit supplement materials in order according to request of Notice about Health Food Evaluation Opinion online. The supplement materials shall be completed and stamped with the same seal as the original applicant.
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	One enterprise cannot register one formula with different health food names and cannot register one product name for different formula health foods.
6	When resubmitting the registration application after receiving disapproval decision, the product name shall be same with the first-time applied name, and copy of the Disapproval Decision Letter (stamped with applicant’s seal), as well as the resubmission reasons shall be submitted at front of the application materials.

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 applicants 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	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.

3. Registration dossier requirements for product containing health food new raw material

There are two types of health food new raw material:

I. Health food new raw material that is not included General Food, Registered New Food Raw Materials, Traditional Substances Served as General food and Traditional Chinese Medicine and Raw Materials Proposed into Health Food Raw Materials directory;

II. Health food new raw material is produced from General Food, Registered New Food Raw Materials, Traditional Substances Served as General food and Traditional Chinese Medicine and Raw Materials Proposed into Health Food Raw Materials directory to have significant changes in the Purity or Material Structure, for example, 99% resveratrol extracted from grape skin is health food new material in China.

Safety assessment materials of the health food new raw material shall be additionally prepared according to the requirements of new food raw materials except the health food registration dossier requirements.

4. Registration dossier requirements for product containing extract

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, which include raw material source, manufacturing technique, extract rate and sense requirements, general quality control index, pollutant index, pesticide residue, characteristic ingredients index, microbiological indicator, etc.; Functional components/characteristic ingredients of product technical requirement should include at least one characteristic ingredient of the extract. If not, the reasons shall be illuminated. Submit total items self-test report of extracts according to the quality requirements.

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