Detailed Rules on Health Food Registration Technical Evaluation

On 8 June 2016, China Food and Drug Administration (CFDA) released the Detailed Rules on Health Food Registration Technical Evaluation (draft for public comment) which applies to the technical evaluation of the health food registration, technology transfer, registration alteration and registration renewal. CIRS has summarized and analyzed the technical evaluation procedure and requirements for health food registration as follows:

1. Technical evaluation procedure for health food registration

2. Duration for the Registration Technical Evaluation

S.N.

Procedure

Duration

1

Accepting center transfers all the application materials to evaluation center

Within 3 workdays

2

Evaluation center finishes the technical evaluation (time needed for on-site verification, re-test, re-evaluation are excluded)

Within 60 workdays (In special circumstances, the period can be extended to 80 workdays)

3

Applicant supplements documents

I. Supplement documents in one lump sum within 3 months;

II. The evaluation starts from scratch after the evaluation center receives the supplementary documents.

4

Verification center conducts on-site verification

Within 30 workdays (For imported health food, case by case)

5

Re-test institute conducts re-test

Within 60 workdays (For imported health food, case by case)

6

Evaluation center sends the comprehensive evaluation conclusion and its suggestions to CFDA

Within 5 workdays

3. Technical evaluation detailed requirements

S.N.

Technical evaluation item

Detailed requirement

1

Safety evaluation

Including evaluations on application basis of raw materials and excipients, safety confirmation report, safety test assessment documents, literature search and selection report and other relevant information.

2


Health function evaluation

Including evaluations on health function confirmation report, function assessment material, human consumption evaluation materials, literature search and selection report t and other relevant information.

3

Production process evaluation

Including evaluations on manufacturing technique research and production process materials and other relevant information.

4


Product technical requirement evaluation

Including evaluations on product technical requirement research, product stability investigation, testing samples, functional component or characteristic ingredient, hygiene health and stability testing report and other relevant information.

5


Label and specification evaluation

The information on the label and specification shall be normative, integrated and complying with current regulation, technical specification and mandatory standard. And it shall be in accordance with its R&D report.

To get detailed requirements of above-mentioned dossier, please read Requirement for Health Food Registration Dossier

6


Technical evaluation conclusion

I. Evaluation institute will make evaluation conclusion as “recommend registration approval”, ”supplement documents and re-evaluate”, “recommend registration disapproval” or “further research verification” on the basis of evaluation situation.

II. Hereinto, the main reasons for “recommend registration disapproval” are listed in below:

- The application dossier is inconsistent and truth of the dossier is dubious, or applicant hasn’t provided traceability materials as required, or doesn’t supplement the documents within time limit etc;

- Product safety, health function or quality controllability doesn’t meet the standard;

- The verification of testing method for functional component or characteristic ingredient hasn’t been conducted.

- The product stability testing is not integrated or conformity with regulations;

- Belong to filing product;

- The product of supplementing vitamins and minerals does not comply with the raw material approval standard stipulated in Administrative Measures on Health Food Function Directory and Raw Material Directory;

- The conclusion of on-site verification is “Not meet the standard” or the conclusion is unclear.

7

On-site verification

- The verification team of CFDA dynamically checks the reasonability and feasibility of product process in accordance with verification notice and R&D report, formula, manufacturing technique and other technical requirements in application dossier.

- After on-site verification, verification team shall notify and confirm evaluation conclusion to applicant.

- Verification team seals the samples that comply with the on-site verification requirements and sends them to re-test institute. With any objections to disapproval decisions made by CFDA, the applicant can submit a written application for re-review.

8

Re-test

- Re-test institute shall conduct testing according to the testing method and its specification in the application dossiers strictly. The re-test includes the verify scientificity, reproducibility and applicability of testing method, and the product quality controllability.

- After the re-test, the re-test report shall be submitted to accepting institute under CFDA.

- The re-test conclusion issued by re-test institute should be clear.

9

Comprehensive technical evaluation conclusion and suggestion

I. Situation of “recommend registration approval”

- The conclusion of application dossier evaluation is “recommend registration approval”, and the conclusions of both on-site verification and re-test meet the requirement;

II. Situation of “recommend registration disapproval”

- The conclusion of application dossier evaluation is “recommend registration disapproval”;

- The conclusions of both on-site verification and re-test don’t meet the requirement;

- After re-evaluation, the evaluation institute insists on “recommend registration disapproved”.

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Original Link: http://www.sda.gov.cn/WS01/CL0782/155345.html