Issued on: 2013-12-05
Issued by: CFDA (China Food and Drug Administration)
I.Project name: health food approval
II.Content of licensing: Registration of imported health food products (incl. from Hong Kong, Macao and Taiwan)
III.Basis for implementation: “People’s Republic of China Food Hygiene Law,” “Provisions for Health Food Registration (Interim)”, “Focuses for Acceptance and Inspection of Health Food Examination and Approval”
IV.Fees: No charge
V.Quantity restrictions: No quantity limit for the licensing
VI.List of application documents:
Data number (1) Imported health food registration application form;
Data number (2) Copies of applicant’s ID card, business license or legally registered certificates of other institutions;
Data number (3) Retrieval information (retrieved from CFDA government website database) proving that the generic names of the health foods being applied don’t overlap with the names of products already registered;
Data number (4) Letter of guarantee ensuring non-infringement of patents already obtained by others
Information Number (five) Provide trademark registration certificates (unregistered trademarks can do without);
Data number (6) Product development report (including research and development ideas, feature selection process, the expected functions, etc.);
Data number (7) Product formulation (APIs and excipients) and formula basis;
Data number (8) Functional components/ Characteristic ingredients, contents and functional components / testing methods of characteristic ingredients;
Data number (9) Production process diagram and detailed description, and the associated research data;
Data number (10) Product quality standards and preparation explanations (including quality standards of APIs and excipients);
Data number (11) Types, names, quality standards and selection basis of packaging materials in direct contact with the product;
Data number (12) The testing report issued by the testing institutions and related information;
Data number (13) Samples of product labels and package inserts;
Data number (14) Technical requirements and Confirmation form of successful upload of technical requirements;
Data number (15) Other information that helps product review;
Data number (16) two samples of minimum unopened sales package;
Data number (17) If the functions are not within the scope of CFDA announced items, relevant documents shall be provided as required;
Data number (18) Certifying documents issued by related institutions of the country or region of origin proving GMP compliance of the manufacturer;
Data number (19) For registration affairs run by overseas manufacturer’s Permanent Representative in China, a copy of the “registration certificate of overseas enterprise’s permanent Chinese representative offices” shall be provided; for registration affairs run by domestic agencies entrusted by overseas manufacturers, the applicant shall provide the original notarized certificate of entrustment and copies of business license of the agencies entrusted;
Data number (20) Documents proving that the product has been marketed more than a year in the producing country (region), which shall be notarized by notary institutions of the producing country (region) and confirmed by the Chinese Embassy in the country;
Data number (21) Product-associated standards issued by the product producing country (region) or international organizations;
Data number (22 ) Real samples of the packaging, labels, package inserts for products marketed in the producing country (region), which shall be attached to the corresponding entries in the application form;
Data number (23) Three consecutive batches of samples, the number of which shall triple the amount required for testing.
VII.Requirements for application dossier:
(I) General requirements for the dossier:
1. The first page of the dossiers is a list of the application documents, which shall be arranged in order required by the “attached information” in “Health food registration application form”. Each dossier shall have a cover page indicating the name of the product and the applicant, and the dossier title shall be marked at the upper right corner. The dossier shall be distinguishable with clear markers, and the name and serial number of the dossier shall be indicated. The full set of dossier shall be punched and bound into a book.
2. The application dossier shall be printed in A4 size paper (Chinese characters not less than font-size junior 4 in Song typeface, English not less than font-size 12), the contents shall be complete, clear, without alteration.
3. Registration application for new products shall provide 1 original and 8 copies of application dossier. Copies shall be fully identical with the original and shall remain intact and clear.
4. Except for the “Imported health food registration application form” and testing reports issued by testing institutions, the application dossier shall be stamped page by page or cross-page stamped (for joint application, the seals of all applicants shall be stamped), and the seal shall be stamped in the text place. The seals shall comply with the state’s relevant provisions for standard management and legally binding. If the applicant for imported health food has no official seal, the dossier can be stamped with seal or signed by the legal representative instead.
5. For joint application, the applicants shall provide a letter of recommendation of the person in charge.
6. The same content in the application dossier (eg product name, name of the applicant, the applicant’s address, etc.) shall be consistent. The same content of electronic version and text version (product name, name & address of the applicant, product formulation, development unit name & address, product acceptance number) shall be consistent.
7. Foreign language in product formulations, production processes, quality standards, labels and package inserts and other relevant documents shall be translated into standard Chinese; the same rule applies to the abstracts, keywords and contents related to product health functions and safety in foreign references (except for foreign names and addresses).
8. Dossier for non-initial application shall provide the copy of the Notice for Withdrawal of Review or Notice of Disapproval (stamped with official seal of the applicant), as well as the grounds for re-application, which shall be attached to the dossier’s first page.
(II) Specific requirements for application documents:
1. Imported health food registration application form;
(1) Imported health food registration application forms can be downloaded from CFDA website (www.cfda.gov.cn) or CFDA Health Food Evaluation Center Web site (www.bjsp.gov.cn).
(2) The form shall be filled as per the requirements of detailed instructions.
(3) The contents of the application form must be printed to fill in, the entries shall be complete, standardized and without alteration.
(4) Health functions being applied shall be consistent with those announced by CFDA. Except for application of new functions.
(5) The applicant of imported health food products shall be the owners of the products, while manufacturers of the products are the actual producers (if the applied product are produced by the applicant, the manufacturer is the applicant; if the applied product is produced by overseas enterprises upon entrustment, the manufacturers shall be entrusted enterprises).
(6) Product name shall include the brand name, generic name and attribute names.
2. Copies of applicant’s ID card, business license or legally registered certificates of other institutions; The copies shall be clear, complete, and stamped.
3. Non-duplication retrieve information of the Generic name of the applied health food and names of registered drugs
(1) Explanations for Non-duplication retrieve.
(2) Printed webpage from CFDA government website database retrieval proving non-duplication of the Generic name of the applied health food and names of registered drugs.
4. Letter of guarantee ensuring non-infringement of patents already obtained by others
(3) The applicant’s letter of commitment shall cover patents inquiry relating to the health food, to prove that the application does not involve and infringe existing patent rights of others, to ensure non-infringement, and assume full responsibility for possible consequences of infringement.
5. Trademark registration certificates (unregistered trademarks need not to provide).
(4) Copies of trademark registration certificates issued by the national trademark registration authorities, unregistered trademarks need not to provide such documents. The application scope of the trademark shall cover the health food, if trademark holders are inconsistent with the applicants, certifying documents shall be provided to prove the change of trademark holders or eligibility of the applicant use of the trademark. The copies shall be clear, complete, and stamped.
6. Product development report (including research and development ideas, feature selection process, the expected functions, etc.); Including three indispensable aspects: research and development ideas, feature selection process, the expected functions, the contents shall be listed separately.
7. Product formulation (APIs and excipients) and formula basis;
(1) Product formulation (APIs and excipients).
(2) Formulation basis.
(3) List the names and dosage of APIs in required format for formulations.
(4) Product formulation (APIs and excipients) and formulation basis shall be listed separately and completely.
8. Functional components/ Characteristic ingredients, contents and functional components / testing methods of characteristic ingredients;
1. Testing methods for functional components/characteristic ingredients and functional components/ characteristic ingredients shall be listed separately and completely.
9. production process diagram and detailed description, and the associated research data;
(1) Diagram and detailed description of the production process and the associated research data shall be listed separately, completely and consistently.
(2) Production process diagram shall contain all of the process lines, links, and specify all processes and related technical parameters.
(3) Detailed description of the production process shall cover all aspects of the production process as well as all technical parameters; indicate the appropriate equipment and model used in all links of production; if extracts are used as APIs, production process of the extracts shall be provided.
(4) Relevant research data.
(5) Three batches testing reports.
(6) Health food produced by applying macroporous resin separation and purification process shall follow the “Regulations for application and review of health food produced by applying macroporous resin separation and purification process (interim).”
10. Product quality standards and preparation explanations (including quality standards of APIs and excipients);
(1) The name of the applicant (if any) in the enterprise standard shall be consistent with that in the application form.
(2) The Appendix of enterprise standard shall be itemized and complete.
11. Types, names, quality standards and selection basis of packaging materials in direct contact with the product;
(1) The name (type) and the quality standard of the packaging material shall be provided.
(2) Certifying documents for source of packaging material shall be provided.
(3) Selection basis of the packaging materials.
12. The testing report issued by the testing institutions and related information;
(1) The testing institutions issuing testing reports shall be CFDA designated health food testing institutions The validity of testing report is five years since issuance, overdue testing report shall not be accepted.
(2) The testing report shall be arranged in the following order:
① Testing application form (attached to the corresponding testing report).
② Notice of Acceptance by testing institution (attached to the corresponding testing report).
③ Safety and toxicology testing report.
④ functionality testing report (including functionality testing report of animals and/or human test-meal report).
⑤ Stimulants, illicit drugs testing report (for registration application for functions relieving physical fatigue, weight loss, improving growth and development).
⑥ Testing report of functional components or characteristic ingredients.
⑦ Stability testing report.
⑧ Hygiene health testing report.
⑨ Other testing reports (such as APIs species identification reports, strain virulence testing reports, etc.).
(3) Testing reports shall meet the following requirements:
① Testing report format shall be standardized, without alteration.
② Signature of testing institution’s legal representative (or authorized person) and official seal of testing institutions.
③ The conclusion of the testing report shall be stamped with the official seal of the testing institution, and testing report more than one page must be cross page stamped or stamped page by page
(4) The product name, delivery units, sample production or development unit name and batch number in the testing report shall be consistent with the corresponding contents in the application form. If changes occur, the applicant and the testing institution must provide written explanations.
(5) For registration application for health food supplements & nutrients, functionality testing report isn’t required; and written explanations must be made for absence of safety & toxicology testing reports.
(6) The copies of certifying documents issued by the Ethics Committee for approval of human testing meals shall be added to the application documents. The copies shall be stamped with the seal of testing institutions, and attached to the human test-meals report.
(7) For an applicant’s registration application of products with different dosage forms but identical APIs and excipients, the applicant shall provide scientific and rational basis for the choice of dosage forms. If all testing reports have been provided for registration of one dosage form of the product, the registration of other dosage forms can be dispensed with safety, toxicology and functionality testing, but relevant explanations must be provided, together with the copies of all safety, toxicology and functionality testing that have been performed.
(8) For registration of health food products with the same APIs and primary excipients but different flavors and colors, if one product registration has provided all testing reports, the registration for the other can be free of toxicology, safety and functionality testing, but explanations must be made for such exemptions, together with copies of all previous toxicology, safety and functionality testing reports.
13. Samples of product labels and package inserts;
The samples of product labels and insert sheets shall be provided in line with the “Requirements for application dossier for health food registration (interim)”.
Health food’s applicable population, inapplicable population and precautions shall be determined based on the functions and characteristics of the product, and relevant documents shall be provided according to the “Supplementary requirements for health food application and review (interim)”.
14. Technical requirements and Confirmation form of successful upload of technical requirements;
15. Certifying documents issued by related institutions of the country or region of origin proving GMP compliance of the manufacturer
(1) If the applied product is produced by overseas manufacturers upon the applicant’s entrustment, the applicant shall provide documents proving that the manufacturer has been trusted, as well as the certificate of entrustment.
(2) The certifying documents shall specify the name of institution issuing the documents, product name, manufacturer name and date of issuance.
(3) The institution issuing the documents shall be authorities or industry associations of the producing country.
16. Registration affairs run by Overseas Pharmaceutical Manufacturers’ Permanent Representative Agencies in China shall provide a copy of “Registration certificate of Overseas Pharmaceutical Manufacturers’ Permanent Representative Agencies in China”.
For registration affairs run by domestic agencies entrusted by overseas manufacturers, the applicant shall provide the original notarized certificate of entrustment and the copies of business licenses of the agencies.
The certificate of entrustment for registration shall meet the following requirements:
(1) The Certificate of entrustment shall specify the name of the units issuing the certificate, name of the entrusted unit, product name for entrusted application, entrusted affairs, and issuance date of the certificate.
(2) The name of the entrusting party issuing the certificate of entrustment shall be fully consistent with the name of the applicant.
(3) If the entrusted party commissioned again another agency to run registration affairs, the applicant’s original certification documents shall be provided together with its Chinese translation, which shall be notarized by domestic organizations in China.
17. Documents proving that the product has been marketed more than a year in the producing country (region), which shall be notarized by notary institutions of the producing country (region) and confirmed by the Chinese Embassy in the country;
The documents proving that the product has been marketed in the producing country (or region) for more than a year shall meet the following requirements:
(1) Specify the name of institution issuing the document, applicant name, manufacturer name, product name, and date of issuance.
(2) Documents shall clearly indicate that the product meets the national (or regional) law and related standards, and is permitted for production and marketing in the country (or region). If a product is only allowed to be produced in the country (or region), but not to be marketed in the country (region), the registration application for such a product shall be inadmissible.
(3) The institution issuing the documents shall be authorities or industry associations of the producing country.
18. Product-associated standards issued by the product producing country (region) or international organizations;
19. Real sample of package, labeling and package inserts for listed product in producing country (region). Shall be included in the entry of samples of label and package insert.
20. Other information that helps product review;
(1) Provide legal registration documents of APIs manufacturers.
(2) Provide testing reports for APIs and excipients.
(3) Provide APIs purchase and sales invoices In the case of donated raw materials, the applicant shall provide proof issued by materials manufacturer; if the applicant purchased raw materials from distribution units, a copy of the supply contract between the distributor and the material manufacturer shall be provided.
(4) If extracts are used as raw materials, the production process and quality standards of extracts shall be provided, and stamped with supplier’s seal.
(5) Commissioned processing agreement signed by the applicant and sample trial production units.
(6) Samples trial production units’ valid business license, and health permit which contains the dosage forms of the applied product.
(7) If the formulations used fungi, probiotics, nucleic acids, endangered wildlife, coenzyme Q10, soy isoflavones and other materials that have been clearly regulated, the applicant shall provide related information as required, in addition to the documents submitted in line with the “Provisions for health food registration management (interim)”.
(8) For products taking synthetic chemicals as materials, the basis for edibility, dosage and safety evaluation data shall be provided.
(10) The first page shall clarify the names, classifications and directory of the dossier, and use clear identification mark to distinguish various documents and data.
21. Three consecutive batches of samples, the number of which shall triple the amount required for testing.
22. Two samples of minimum unopened sales package;
The sample package shall be complete, intact, and labeled, the label shall be consistent with the corresponding content in the documents. The samples package shall be conducive to preservation, non-perishable and non-breakable. The samples shall be within the validity period.
23. The above application documents must be in Chinese and attached with the original language, foreign language information can be attached as a reference. The Chinese translation shall be notarized by domestic notary institutions to ensure consistency with the original contents; the quality standard (Chinese version) of the applied product must comply with the format of Chinese health food quality standards.
24. The following shall also be noted:
(1) The applicant of imported health food products shall be the owners of the products, while manufacturers of the products are the actual producers (if the applied product are produced by the applicant, the manufacturer is the applicant; if the applied product is produced by overseas enterprises upon entrustment, the manufacturers shall be entrusted enterprises).
(2) The name of the product, applicant, manufacturer, and agencies (Chinese and English) shall be consistent.
(3) The certifying documents and certificate of entrustment shall be original, the official text of the producing countries (or regions) shall be notarized by notary authorities of the country (or region) and confirmed by the Chinese Embassy (consulate)in the country.
(4) The documents and certificate of entrustment shall be within the validity period (if any).
(5) Documents and certificate of entrustment shall be stamped with the official seal or signed by legal representative (or other licensors).
VIII.Application process diagram:
After the application is filed to the Administrative Acceptance Service Center, and the application dossier submitted is in accordance with the list in VI of this Notice, the format examination shall be conducted by the work staff of the Center in accordance with the “Provisions for Health Food Registration” Annex I: Application dossier for registration of imported health food products “. Where the application item is not subject to administrative approval according to law, a decision of non-acceptance shall be notified to the applicant immediately. Where the application item is not within the functions of the administrative authority, a decision of non-acceptance shall be made immediately, and the applicant shall be informed to launch the application to relevant administrative authority. Where in the application dossier, there are errors that can be corrected on the spot, the applicant shall be allowed to make the corrections on the spot. Where the application dossier is incomplete or does not meet the statutory format, the applicant shall be informed of all the supplements and amendments to be made once and for all on the spot or within five days. If the applicant is not informed within the above-mentioned period, the application shall be deemed as accepted from date of receipt of application materials. Where the application dossier is within the functions of the administrative authority, the application materials are complete and comply with the statutory format, or where the applicant has submitted all supplements and amendments in accordance with the requirements of the administrative authority, the application for administrative approval shall be accepted.
(II)Inspection and verification:
After the application is accepted by the Administrative Acceptance Service Center, CFDA shall issue a notice to the designated testing institution within five days and deliver testing samples. If necessary, CFDA may conduct inspection on the production and testing site of the product.
The testing institutions shall conduct testing and verifications of the samples within 50days upon receipt of the notice and testing samples, the test report will be delivered to CFDA, and copied to the applicant. Under special circumstances, if the testing institutions cannot complete the testing within the required time limit, they shall promptly report to CFDA and deliver a written explanation.
(III)Technical review and administrative review:
CFDA shall conduct technical review and administrative approval within 80 days after accepting the application, and make licensing decisions. During the review process, CFDA shall propose requests for supplementary information once for all to the applicant. The applicant shall submit supplementary information as required within five months after the receipt of requests, in case of failure of submitting the supplementary information within specified time limit, the application shall be rejected for review. In case the applicant can’t submit the supplementary information within specified time limit under special condition, he /she shall apply to CFDA in written and provide reason, CFDA shall make settlement opinions within 20 days. The time for submission of supplementary information shall not be included in the time frame of licensing, the time limit of its review shall be extended by 30days on the basis of the original one. “Approval Certificate for Health Food Made in China” shall be issued to qualified applications. Written explanations shall be given to rejected applications.
Within 10 days from the date of decision making of administrative approval, CFDA Administrative Service Center shall deliver the decision to the applicants.
With any objections to disapproval decisions made by CFDA, the applicant can submit a written application for re-review within 10 days upon receipt of the decision and elaborate the reasons.
After receiving the application for re-review, CFDA shall re-review the application in accordance with the original time limits and requirements, and make a decision for re-review. If the registration disapproval decision is revoked, the appropriate health food approval documents shall be issued to the applicant; if the original decision is maintained, repeated application for re-review shall no longer be accepted, but the applicant can apply to CFDA for administrative reconsideration or bring an administrative lawsuit to the people’s court in accordance with relevant laws and regulations.
X.Commitment time frame:
The administrative licensing decision shall be made within 85 days from the date of acceptance.
XI.Authority of Implementation:
Implemented by: CFDA
Accepted at: CFDA Administrative Service Center
XII.License validity and renewal:
“Imported health food approval certificate” is valid for five years, if it’s validity period is to be extended after the expiry, the applicant shall apply for renewal three months before the expiry.
XIII.Annual inspection or annual review of the license: None
XIV.Institutions for inquiries and complaints:
Complaints: CFDA Bureau of Investigation and Enforcement, Department of Legal Affairs
Note: The time frame of this Notice counts on working days, excluding legal holidays
Related reading: The updates of China health food related regulation