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CFDA Registration cost and timetable for Nutritional supplements(Dietary supplements)

 

In China, Health Foods are divided into 2 parts, they are Nutritional supplements (Dietary supplements) and Function Healthy Foods

1. Nutritional supplements (Dietary supplements) : Such as:Vitamin, Calcium tablet, etc. Nutritional supplements only can be made nutrient content claims.

2. Function Healthy Foods : Such as: Deep Sea Fish Oil, Ginseng tablets, etc.. Function Healthy Foods can be made health claims or structure/function claims,

l The following is the CFDA registration general cost for Healthy Foods♀o

1.The CFDA relation goverment fees(charge According to the actual cost):

Item

Fee

Time

Toxicology, hygienic, stability, active ingredient tests:

Both Nutritional supplements and Function Healthy Foods are required,

Inquire us

4 Months

Function Tests & Human Trial Study

Function Healthy Foods Only

Animal study only:

1. Enhancing immune systems

2. Sleep improvement

3. Alleviating physical fatigue

4. Enhancing anoxia endurance

5. Irradiation hazard protection function

6. Increasing bone density

7. Assisting liver protection against injury

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6-9 Months

Human study only:

8. Alleviating eye fatigue

9. Eliminating acne

10. Eliminating skin pigmentation

11. Improving skin ability to retain moisture

12. Improving skin oil content function

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8-12 Months

Both Animal & Human studies are required:

13. Assisting blood lipids reduction

14. Assisting blood sugar reduction

15. Anti-oxidative function

16. Assisting memory improvement

17. Alleviating lead excretion

18. Improving throat function

19. Assisting blood pressure reduction

20. Facilitating milk secretion

21. Assisting weigh control

22. Improving child growth

23. Improving nutritional anemia

24. Regulating gastrointestinal flora

25. Facilitating digestion (regularity)

26. Facilitating bowel movement

27. Protection of gastric mucosa

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12-18 Months

Doping test: only for the 3 functions of the follow

3. Alleviating physical fatigue

21. Assisting weigh control

22. Improving child growth

Inquire us

1 Months

CFDA Evaluation & Approval

Inquire us

6 Months

Total

18-24 Months

l Multi-function claim, need more time and expense.

2.The china legal agent service Fees:

1) for Nutritional Supplements (Dietary supplements) :

ITEM

Agent Fees

TIME

NOTE

China CFDA Registration consulting & Legal responsibility Agency

Inquire us

0.5-1 Months

Technical documents Prepare & Translation

Inquire us

0.5-1 Months

CFDA Application Dossier Draft, Review & Submit

Inquire us

1 - 2 Months

Toxicology, hygienic, stability, active ingredient tests follow up

Inquire us

4 - 6 Months

CFDA Evaluation & Approval follow up

Inquire us

6 - 8 Months

Other (Document Notarization etc.)

USD$500

0.5-1 Months

Total:

Inquire us

18-24

Months

2) for Function Healthy Foods:

ITEM

Agent Fees

TIME

NOTE

China CFDA Registration consulting & Legal responsibility Agency

Inquire us

0.5-1 Months

Technical documents Prepare & Translation

Inquire us

0.5-1 Months

CFDA Application Dossier Draft, Review & Submit

Inquire us

1 - 2 Months

Toxicology, hygienic, stability, active ingredient tests follow up

Inquire us

4 - 6 Months

*Function tests /Animal Study

(for Function No. 1-7)

Inquire us

4 :C 16 Months

*Function tests/Human Trial

(for Function No. 8-12)

Inquire us

8 - 12 Months

*Function tests/Human Trial + Animal Study

(for Function No. 13-27)

Inquire us

12 - 18 Months

CFDA Evaluation & Approval

Inquire us

5 :C 8 Months

Other (Document Notarization etc.)

Inquire us

0.5-1 Months

Total:

Inquire us

24-36

Months

l Multi-products registration,the agent fee can discount

 
CFDA,china fda,china drug,pharma,otc,medical device,healthy food,cosmetics,registration,cro,clinical trial

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