Detailed Rules on Registration Dossier and On-site Inspection of Formula Registration of Infant Formula Milk Powder

On 12 August 2016, China Food and Drug Administration (CFDA) published the supportive documents of formula registration of infant formula milk powder (draft) for public comment. Opinions and suggestions can be given before 10 September. The supportive documents are based on “Administrative Measures on Product Formula Registration of Infant Formula Milk Powder” and include requirements on registration dossier and on-site inspection. CIRS collates the key points as follows:

1. General requirements on application dossier

S.N.

Requirements

1

Fill out the application form online and print it.

2

The first page of the dossiers is a list of the application documents.

3

I. Each dossier item shall have its cover page (indicating product name, applicant name and material name);

II. Different dossiers shall be distinguishable with clear markers.

4

I. The application dossiers shall be printed in A4 size paper;

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

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

5

I. Application dossiers (except application form and testing report issued by testing institutions) shall be stamped with applicant seal page by page or across the page;

II. The seal shall be stamped in the text place.

6

Application information must be true and correct.

7

Applicant subject qualification certificate, raw material quality and safety standards, formulation, product processing, test report, label, specifications and related certificates should be translated into standard Chinese.

8

Applicant shall submit supplement materials in order according to the request of Notice about Infant Formula Milk Powder Formulation Evaluation Opinion and the Notice shall be attached behind supplement material.

9

Registration application dossier shall consist of 1 original dossier, 5 copies and 1 electronic version.

10

Application dossiers will not be refunded for unapproved product formulation, except for the proxy.  

2. Application dossier items and requirements

S.N.

Dossier items

Requirements

1

Application form

I. Each product can have only one product name which consist of trade name and common name;

II. If the product has been sold before, product name, time to market, country of sale should be stated.

2

Applicant subject qualification certificate

Copy of subject registration documents of applicant, copy of trademark registration certificate (if necessary), guarantee of non-infringement of other patents etc. should be submitted;

For import product, certificate of manufacturer registration under CNCA, proxy (if necessary) etc. should be provided additionally.

3

Raw material quality and safety standards

Quality and safety standard as well as the implementation standard of food raw materials and food additives should be submitted.

4

Product formula

Ingredients list, ingredients list with percentage, specification and standard number and nutrition information should be included.

5

Product formula  development report

I. State the formula feature, formula principle, development purpose etc.;

II. Provide evidentiary materials to prove formula scientificity and safety, such as test materials, regulations in domestic and overseas etc.;

III. Provide the development and demonstration reports, such as nutrients values determinant factor, raw material nutrient data research etc.;

IV. State the source, function, dosage etc. of food raw materials and food additives;

V. Tracking evaluation scheme on nutrient and safety should be included.

VI. Formula difference should be stated if the applicant applies for the approval of two or more formulas with same stage.

VII. Requirements and basis of production processing, environmental conditions, production equipment etc. and verification on production processing should be included.

6

Production processing

Production process flow and technical parameters should be stated.

7

Trial sample test report

All items testing report on 3 batches of samples under pilot test or above size shall be provided. Hereinto, at least one batch of samples should be produced under commercial production line.  

8

Evidentiary materials on production capacity, development capacity and inspection capacity

Information of production staff, research staff and inspection staff, inspection institution and qualification certificate (for overseas applicant) etc. should be provided.

9

Other evidentiary materials on formula scientificity and safety 

For instance, test report, invoice, contract etc. of food raw materials and food additives, tracking analysis report (for marketed products) etc. should be provided.

10

Samples of label and specification and related certificates

I. Content in product label should be in accordance with that in specification.

II. Chinese label and specification are required for imported infant formula milk powder.

III. Evidentiary materials of product formula claims should be included.

IV. Some contents are forbidden in label and specification, please click here for details.


3. On-site inspection items

CFDA examination agency will conduct the on-site inspection from below aspects to evaluate the manufacturer capacity.

S.N.

Category

Items

1

Production conditions

Production workshop

Production distribution

2

Quality control

Organization structure

Quality management system

Quality control system

Handling with unqualified situation

Production control and process file

Key control point

Purchase system

Purchase file

3

Inspection capacity

Organization structure

Examining system

Lab layout

Examination facility, instrument and equipment

4

Development capacity

Development institution

Development system

5

Small trail capacity

Operator requirement

Sample development situation

Pilot production equipment

Inspection equipment

Food raw material and food additives

Consistency of pilot production

These two drafts have stipulated the formula registration details of infant formula milk powder. Although the final version may be changed slightly based on them, related enterprises should get ready to the coming registration in advance to complete formal registration quickly and smoothly.

If you have any other questions, please contact us at service@cirs-reach.com


Original

CFDA published the supportive documents of formula registration of infant formula milk powder (draft) for public comment