This guidance is for the clients who want to have some professional scientific evidence to prove the function of the products and have some function claim on the product. Usually we do as follows:
Step 1. 6 months feeding test on animals
Before we do clinical trial, we must conduct animal tests firstly to make sure the product is safe:
Time: 6 months
Total fees: 80,000 RMB (Including basic tests such as physical and chemical tests)
Institution which can do it: ZheJiang Institute For Food and Drug Control
Step 2: Submit the clinical trial application to Ethics Committee for approval
If you want to do clinical trial, you have to firstly obtain the approval of Ethics Committee then you can conduct the human test.
Time: 8 months
Total fees: 250,000-300,000 RMB
Hospital: A Hospital in Tianjin. We can just use the hospital worked with the Lab, and the lab will handle with the test progress.
Step 3: Obtain the final report
Fees of report: 20,000-40,000 RMB
Another fees- Methodology verification
There is another item we must do called Methodology verification, which will check if the testing method you use is scientific.
Fees: 30,000-50,000 RMB
Institution which can do it: Health analysis center, Nanjing Medical University
If you want to do clinical trials, Knudsen CRC can help you with it.