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.
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No.
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Format requirement for application
dossier
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1
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-
The first page of the dossiers is a list of the
application documents;
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Each dossier item shall has its cover page (indicating
product name, applicant name and material name);
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Different dossiers shall be distinguishable with clear
markers;
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The full set of dossier should be punched and bound
into a book.
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2
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-
The application dossiers shall be printed in A4 size
paper;
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Chinese characters shall be no less than font-size
junior 4 in Song typeface;
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English shall not be less than font-size 12.
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3
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-
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;
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The seal shall be stamped in the text place.
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If there is no seal for imported product registration
applicant, the seal shall be replaced by legal representative signature or
signature seal.
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4
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-
Certificate, label and specification with foreign
languages, abstract and keyword in foreign references should be translated
into standard Chinese;
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Product information about safety, health function and
quality control shall be translated into standard Chinese.
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5
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-
Original, copy and electronic version of application
dossiers should be submitted;
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The content on the copy and electronic version should
be consistent with original dossier;
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Registration application dossier shall consist of 1
original dossier and 9 copies.
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6
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-
Registration application form, product formulation,
label, specification and product technical requirement should be filled in
online and then printed.
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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.
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7
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-
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.
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No.
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General requirement for application
dossier
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1
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-
Scientific proof about technical requirement (formula,
process, etc.);
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Scientific proof about product safety, health function,
quality control, etc.
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2
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Sample for testing and research shall be prepared by
pilot scale process, and the workshop and manufacturing process shall comply
with GMP.
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The sample for initial imported registration
application must have been sold in manufacturing country (region).
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3
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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.
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4
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Original research and testing record, instrument and
equipment usage record, and original pilot scale production record should be
kept regularly in case authority inspects.
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5
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One enterprise cannot register one formula with
different health food names and cannot register one product name for
different formula health foods.
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6
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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.
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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.
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No.
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List
of domestic products registration dossiers
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Specific requirements
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1
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Health food filing application form; Letter of
commitment for authenticity of the materials;
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Fill in the registration form through the health food
registration application system under CFDA and print the application form.
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2
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Copies of legally registered certificates
of the applicant;
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Provide the Enterprise Legal Person Business
License or Public Institution Corporate Capacity Registration
Certificate
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3
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Product development report
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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;
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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;
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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.
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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.
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4
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Products formulation material
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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.
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5
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Production process material
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Provide the main producing flow chart and detailed
instructions, key process control points and instructions.
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6
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Safety and health function assessment material;
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Legal qualification certification
of food test institution.
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Safety test assessment dossier issued by legal qualification
test institution;
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Health function test assessment dossier issued by legal
qualification test institution;
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the crowd edible evaluation material issued by legal
qualification test institution (Involve
the human health function test);
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3 batches products tests reports of functional
components/characteristic ingredients, hygiene health and stability issued by legal qualification
test institution;
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Strain identification report issued by authority test institution and strain virulence
test report for Probiotics-based Health Food issued by legal qualification
test institution;
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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.
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7
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Information of packaging materials in direct contact
with the product
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Type, name, quality standard number, quality standard text
and use basis of packaging materials in direct contact with the product
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8
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Samples of product label and package insert
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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.
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9
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Retrieval information (retrieved from CFDA government
website database)
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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.
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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.
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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;
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If product uses a registered trademark, the trademark
registration certificate should be provided.
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10
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3 samples with the minimum sales packaging
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The package, label and specification of samples for
imported product shall be corresponding with product on the original market.
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The samples shall be no less than 3 months from the
expiry date.
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11
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Other relevant materials
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Include proof documents, such as enterprise quality
control system proof (GMP, HACCP) copies, original power of attorney,
original literatures copies.
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No.
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Except above dossiers, registration
application on initial imported product also should submit following documents:
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1
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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;
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2
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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;
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3
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Health food-associated standards issued by the product
producing country (region) of origin or international organizations;
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4
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Packaging, labels, package inserts for products
marketed in the producing country (region) of origin;
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5
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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;
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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.
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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
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No.
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Requirements for dossiers
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Specific requirements
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1
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Requirements for formula, safety and function
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-
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.
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2
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Technical requirements
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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.;
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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.
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Submit total items self-test report of extracts
according to the quality requirements.
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For further information of China health food registration
and filing, please kindly click here:
If you have any needs, please contact us at service@cirs-reach.com.
Related Article: CFDA Notice on the release of Health Food Registration Application Service Guideline
